This phase II trial studies how well the addition of 18F-DOPA (amino acid) positron emission tomography (PET)/computed tomography (CT) to standard of care (SOC) imaging can improve the clinical management of patients with brain tumors in over 50% of cases. PET is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. PET/CT scans are hybrid scanners that combine both of the two modalities into a single scan. This allows images of both anatomy (CT) and function (PET) to be taken during the same scan. The 18F-DOPA PET/CT scan is done with a very small amount of a radioactive tracer called FDOPA. The PET/CT scan is then used to detect the location of tumors. Using the 18FDOPA-PET/CT scan in addition to the SOC scan may improve the clinical management of patients with brain tumors.

Start Date11 Nov 2024

Sponsor / Collaborator

Mayo Clinic

NCT05103618

/ Not yet recruitingPhase 2IIT

Evaluating the Physiological and Psychological Effects of a Novel Meditation Technique on Cerebral Activity Measured With Functional Magnetic Resonance Imaging(fMRI) and F-18 Fluorodopa PET Imaging

The purpose of this research is to use 18 F Fluorodopa positron emission tomography (FDOPA PET) to measure dopamine function, and utilize magnetic resonance imaging (MRI) to measure inflammatory and oxidative stress markers in persons with Parkinson's disease.
The overall goal of this study will be to further the understanding of the effects of a novel meditation technique called orgasmic meditation (OM) on these neurophysiological parameters.

Start Date01 Sep 2024

Sponsor / Collaborator

Thomas Jefferson University

NCT05512403

/ RecruitingPhase 3IIT

Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics as Biomarkers for the Improvement of Care of MRI Non-contrast Enhanced Gliomas

the investigators hypothesise that 18F-FDOPA PET kinetic parameters are good biomarkers to characterise suspected LGG brain lesions that exhibit no contrast on MRI, for identifying aggressive lesions. These parameters could constitute diagnostic biomarkers for this indication. This new diagnostic tool could enhance patient care in the short term in an evolving pathology affecting socially active subjects with a poor prognosis

Start Date13 Jun 2023

Sponsor / Collaborator

Centre Hospitalier Regional de Nancy

100 Clinical Results associated with FLUORODOPA F-18

100 Translational Medicine associated with FLUORODOPA F-18

100 Patents (Medical) associated with FLUORODOPA F-18

683

Literatures (Medical) associated with FLUORODOPA F-18

01 Feb 2025·INTERNAL MEDICINE JOURNAL

Clinical utility of ¹⁸F‐fluorodopa positron emission tomography in the movement disorder clinic: an Australian experience

Article

Author: Yeow, Dennis ; Adam, Robert ; Hynard, Shane ; Thomas, Paul ; Fielder, Matthew ; Katz, Matthew ; Lehn, Alexander ; O'Sullivan, John D.

Abstract:

Background:

Differentiating idiopathic Parkinson disease (iPD) from other causes of tremor and parkinsonism based on clinical grounds can be challenging, particularly early in the course of disease or in the case of atypical clinical presentations. 18F‐fluorodopa (F‐DOPA) is a positron emission tomography (PET) radioligand that can be used to demonstrate the presence and pattern of striatal presynaptic dopaminergic deficit and, thus, assist in the diagnosis of iPD and related disorders.

Aims:

To determine the clinical utility of F‐DOPA PET in an Australian movement disorder clinic setting.

Methods:

Retrospective cohort study of movement disorder clinic patients referred for F‐DOPA PET by four movement disorder neurologists over a 10‐year period to a single Australian nuclear medicine centre. Results of F‐DOPA PET scans were correlated with changes in provisional diagnosis and management in the short term following review of F‐DOPA PET results.

Results:

A total of 105 F‐DOPA PET scan results and patient records were examined. In this cohort, provisional clinical diagnosis was altered in 37.9% of patients, and changes to clinical management were made in 48.4% of patients in the short term following review of F‐DOPA PET results. Changes in both diagnosis and management were more common following a normal F‐DOPA PET scan result (42.4% and 53.0% respectively) than a scan consistent with iPD (23.5% and 32.4% respectively).

Conclusions:

There was significant change in provisional clinical diagnosis and management in the short term following review of F‐DOPA PET results indicating significant clinical utility of F‐DOPA PET in the Australian movement disorder clinic setting.

01 Dec 2024·LANCET ONCOLOGY

Short-course hypofractionated proton beam therapy, incorporating 18F-DOPA PET and contrast-enhanced MRI targeting, for patients aged 65 years and older with newly diagnosed glioblastoma: a single-arm phase 2 trial

Article

Author: Liu, Wei ; Uhm, Joon ; Ruff, Michael ; Ashman, Jonathan ; Voss, Molly ; Kizilbash, Sani ; Hu, Leland ; Yang, Ming ; Mrugala, Maciej ; Buras, Matthew ; Porter, Alyx ; Bendok, Bernard ; Breen, William ; Brown, Paul ; Vora, Sujay ; Sio, Terence ; Laack, Nadia ; Brinkmann, Debra ; Mahajan, Anita ; Pafundi, Deanna

BACKGROUND:

Older patients (aged ≥65 years) with glioblastoma have a worse prognosis than younger patients and a median overall survival of 6-9 months. 3,4-Dihydroxy-6-[¹⁸F]fluoro-L-phenylalanine (¹⁸F-DOPA) PET sensitively and specifically identifies metabolically active glioblastoma for preferential targeting. Proton beam therapy potentially improves quality of life (QOL) by sparing more healthy brain tissue than photon radiotherapy. With improved targeting and the dosimetric advantages of proton beam therapy, we aimed to test whether hypofractionated proton beam therapy could improve survival and QOL in older patients with glioblastoma.

METHODS:

In this single-arm phase 2 trial, we enrolled patients aged 65 years and older with an Eastern Cooperative Oncology Group performance status score of 0-2 and newly diagnosed WHO grade 4, malignant glioblastoma from two Mayo Clinic campuses (Phoenix, AZ, and Rochester, MN, USA). Radiotherapy target volumes were defined by ¹⁸F-DOPA PET and MRI regions of contrast enhancement. Patients were given dose-escalated hypofractionated proton beam therapy (35-40 Gy equivalents in five or ten treatments) plus oral concurrent temozolomide (75 mg/m² daily on days 1-7 for the five-treatment regimen or on days 1-14 for the ten-treatment regimen), and 1 month after completing radiotherapy patients were given adjuvant temozolomide (150-200 mg/m² on days 1-5 for six 28-day cycles). The primary endpoint was overall survival at 12 months after enrolment. The primary endpoint and safety were assessed in the intention-to-treat population (defined as all eligible patients who started radiotherapy). This study is registered with ClinicalTrials.gov, NCT03778294, and is now complete.

FINDINGS:

Between May 22, 2019, and May 25, 2021, 43 patients were enrolled, of whom four did not receive treatment because of progression (n=2), death (n=1), or insurance denial (n=1), such that 39 patients received treatment (median age 70·2 years [IQR 67·4-74·3]; 11 [28%] of 39 patients were female, 28 [72%] were male, 37 [95%] were White, one [3%] was Black or African American, and one chose not to disclose their race). As of data cutoff (Jan 30, 2024), median follow-up was 25·4 months (IQR 22·1-29·7). 22 (56% [95% CI 39-72]) of 39 patients were alive at 12 months. Median overall survival was 13·1 months (95% CI 11·1-19·1). Grade 3 baseline-adjusted, treatment-associated adverse events were CNS necrosis (four [10%] of 39) and thrombocytopenia (one [3%]). No baseline-adjusted, treatment-associated grade 4 adverse events or deaths occurred.

INTERPRETATION:

We observed improved overall survival compared with historical controls and a promising adverse event profile by using ¹⁸F-DOPA PET-guided, dose-escalated, hypofractionated proton beam therapy. These findings have resulted in the opening of a phase 2 study (NCT05781321) investigating this regimen versus standard-of-care treatment in adults of any age with newly diagnosed glioblastoma.

FUNDING:

Mayo Clinic Marley Endowment Funds and the Lawrence W and Marilyn W Matteson Fund in Cancer Research.

01 Oct 2024·PARKINSONISM & RELATED DISORDERS

Early detection of dopaminergic dysfunction and glymphatic system impairment in Parkinson's disease

Article

Author: Chen, Yu-Chen ; Yao, Jun ; Shang, Song'an ; Yin, Xindao ; Huang, Ting ; Zhao, Hongdong ; Tian, Youyong ; Li, Rushuai

PURPOSE:

This study aimed to assess the glymphatic function and its correlation with clinical characteristics and the loss of dopaminergic neurons in Parkinson's disease (PD) using hybrid positron emission tomography (PET)-magnetic resonance imaging (MRI) combined with diffusion tensor image analysis along the perivascular space (DTI-ALPS), choroid plexus volume (CPV), and enlarged perivascular space (EPVS) volume.

METHODS:

Twenty-five PD patients and thirty matched healthy controls (HC) participated in the study. All participants underwent ¹⁸F-fluorodopa (¹⁸F-DOPA) PET-MRI scanning. The striatal standardized uptake value ratio (SUVR), DTI-ALPS index, CPV, and EPVS volume were calculated. Furthermore, we also analysed the relationship between the DTI-ALPS index, CPV, EPVS volume and striatal SUVR as well as clinical characteristics of PD patients.

RESULTS:

PD patients demonstrated significantly lower values in DTI-ALPS (t = 3.053, p = 0.004) and larger CPV (t = 2.743, p = 0.008) and EPVS volume (t = 2.807, p = 0.008) compared to HC. In PD group, the ALPS-index was negatively correlated with the Unified Parkinson's Disease Rating Scale III (UPDRS-III) scores (r = -0.730, p < 0.001), and positively correlated with the mean putaminal SUVR (r = 0.560, p = 0.007) and mean caudal SUVR (r = 0.459, p = 0.032). Moreover, the mean putaminal SUVR was negatively associated with the UPDRS-III scores (r = -0.544, p = 0.009).

CONCLUSION:

DTI-ALPS has the potential to uncover glymphatic dysfunction in patients with PD, with this dysfunction correlating strongly with the severity of disease, together with the mean putaminal and caudal SUVR. PET- MRI can serve as a potential multimodal imaging biomarker for early-stage PD.

News (Medical) associated with FLUORODOPA F-18

31 May 2024

·www.pharmaceutical-technology.com

FDA grants RMAT status for BlueRock’s Parkinson’s therapy

Bemdaneprocel is created to replace the dopamine-producing neurons lost due to Parkinson’s disease. Credit: Annick Vanblaere from Pixabay. The US Food and Drug Administration (FDA) has granted a regenerative medicine advanced therapy (RMAT) designation for BlueRock Therapeutics’ investigational cell therapy bemdaneprocel (BRT-DA01) for Parkinson’s disease. Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Top Guide for Drug Delivery Systems BlueRock is a wholly owned independently operated Bayer subsidiary. Bemdaneprocel is claimed to be the most clinically advanced cell therapy for Parkinson’s disease treatment in the US. The therapy is created to replace the dopamine-producing neurons lost in the course of the disease. It was assessed in the multi-site, multicentre, non-randomised, open-label, non-controlled study. See Also: Dupixent gets closer to EU approval as the FDA delays its decision on COPD Bristol Myers Squibb’s Breyanzi gains FDA approval for lymphoma The trial involved 12 subjects diagnosed with Parkinson’s disease who underwent surgical transplantation of bemdaneprocel cells into the post-commissural putamen bilaterally, followed by a one-year immunosuppression regimen. Data from the trial, announced in March 2024, indicated that bemdaneprocel was well tolerated and did not present major safety issues up to 18 months post-treatment. Furthermore, an increase in the F-DOPA PET imaging signal was observed after the cessation of immune suppression therapy at 12 months, suggesting that the transplanted cells survive and engraft in the brain. The RMAT designation is managed by the FDA’s Center for Biologics, Evaluation and Research (CBER). It is specifically for investigational regenerative therapies, including cell therapies, aimed at treating, modifying, reversing or curing serious ailments. Therapies granted RMAT status can benefit from expedited development review and development planning guidance from senior CBER managers. This status also facilitates early discussions about possible surrogate endpoints and strategies to support accelerated approval and satisfy post-approval needs. BlueRock Therapeutics president and CEO Seth Ettenberg stated: “We are excited about the positive data from the bemdaneprocel Phase I clinical trial and believe it has great potential to help patients living with Parkinson’s disease regain functions they have lost to the disease. “Now with this RMAT designation in hand, we look forward to closely collaborating with the FDA to ready this programme for Phase II clinical studies.” Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

Phase 1Cell TherapyGene Therapy

28 Aug 2023

·www.prnewswire.com

BlueRock's Phase I study with bemdaneprocel in patients with Parkinson's disease meets primary endpoint

Investigational cellular therapy, bemdaneprocel (BRT-DA01), was well tolerated with no major safety issues in all 12 participants in low dose and high dose cohorts through one year. At one-year, exploratory clinical endpoints improved overall, with participants in the high dose cohort showing greater improvement. One year assessment of all participants demonstrated feasibility of transplantation, cell survival, and engraftment. Planning is underway for a Phase II study that is expected to begin enrolling participants in H1 (first half) 2024. BERLIN and CAMBRIDGE, Mass., Aug. 28, 2023 /PRNewswire/ -- Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, announced today details of the positive data from the Phase I clinical trial for bemdaneprocel (BRT-DA01), a stem cell derived investigational therapy for treating Parkinson's disease. The data were presented at the International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark. The study met the primary objective of demonstrating safety and tolerability in all 12 participants in the study's low and high dose cohorts, with no serious adverse events (SAEs) reported related to bemdaneprocel through one year. There were two SAEs reported that were unrelated to bemdaneprocel, one seizure attributed to the surgical procedure and one COVID case. Both resolved without sequelae. In addition, 18F-DOPA PET imaging scans demonstrated evidence of cell survival and engraftment in both low and high dose cohorts. 18F-DOPA PET imaging is a neuroradiological technique used to visualize and assess dopaminergic activity in Parkinson's disease. Secondary exploratory clinical endpoints improved in both cohorts, with participants in the high dose cohort showing greater improvement, as assessed by the MDS-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) and the Hauser Diary, which are tools used to assess Parkinson's disease severity in motor symptoms. "The data from this Phase I open label study are extremely encouraging," said Claire Henchcliffe, MD, chair of the UCI School of Medicine Department of Neurology at the University of California, Irvine and one of the study's Principal Investigators. "While this is a small open label study, meeting the study's primary objective for safety and tolerability along with initial improvements seen in clinical outcomes represents a great step forward. The hope now is that these trends continue and translate into meaningful benefit for people with Parkinson's disease in controlled clinical trials." Using the Hauser Diary, which categorizes patients as being in the "ON" state when their symptoms are well controlled and in the "OFF" state when they experience a worsening of their symptoms, participants in the high dose cohort showed an improvement of 2.16 hours in time spent in the "ON" state without troubling dyskinesia compared with baseline after one year. Time spent in the "OFF" state showed a corresponding decrease of 1.91 hours after one year. Participants in the low dose cohort showed an improvement of 0.72 hours in the "ON" state without troubling dyskinesia time compared with baseline and a corresponding decrease of 0.75 hours in "OFF" state time. In the high dose cohort, a one-year measurement of the effects of bemdaneprocel using MDS-UPDRS Part III measured in the "OFF"-medication state, showed a reduction of 13.0 points compared with baseline. The low dose cohort showed a reduction of 7.6 points. "The need for new therapies to help patients struggling with Parkinson's disease is clear," said Ahmed Enayetallah, Senior Vice President and Head of Development, BlueRock Therapeutics. "We are excited to be sharing the results of this Phase I and look forward to advancing bemdaneprocel to the next stage of clinical testing." Based on these results, planning is underway for a Phase II study that is expected to begin enrolling patients in H1 (first half) 2024. "The standard of care for millions of people living with Parkinson's disease has only marginally improved in the past decades, and the existing unmet medical need will only become higher due to the growing aging population," said Christian Rommel, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Research and Development. "The positive outcome of this Phase I clinical trial is a clear step forward, and it brings us closer to delivering new treatment options to patients." About bemdaneprocel (BRT-DA01) and the Phase I Trial Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson's disease. These dopaminergic neuron precursors are derived from pluripotent stem cells (PSC) that are human embryonic stem cells. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson's disease. When transplanted, they have the potential to reform neural networks that have been severely affected by Parkinson's and restore motor and non-motor function to patients. This phase I study is a multi-center, multi-site, open-label, non-randomized, non-controlled study. Twelve (12) subjects received surgical transplantation of 1 of 2 different dose levels of bemdaneprocel cells to the post-commissural putamen bilaterally, and administration of a 1-year immunosuppression regimen. Cohort A (5 subjects) received a dose of 0.9 million cells per putamen. Cohort B (7 subjects) received 2.7 million cells per putamen. Safety and tolerability were assessed at 1 year, along with evidence of cell survival and motor effects. The feasibility of transplantation was also assessed. All assessments will continue over 2 years. The transplant surgeries were performed by Dr. Viviane Tabar, MD, Chair of the Department of Neurosurgery at Memorial Sloan Kettering (MSK) Cancer Center and Dr. Andres Lozano, M.D., Ph.D., F.R.C.S.C., F.R.S.C., F.C.A.H.S., Neurosurgeon and Senior Scientist, Krembil Brain Institute, University Health Network (UHN), Alan & Susan Hudson Cornerstone Chair in Neurosurgery, Toronto Western Hospital, University Health Network and Chairman of the Division of Neurosurgery at the University of Toronto (UoT). Participants were followed at clinical sites by Dr. Harini Sarva, M.D. at Weill Cornell Medicine, Dr. Claire Henchcliffe, M.D., D.Phil., F.A.A.N., F.A.N.A. at the University of California, Irvine, and Dr. Alfonso Fasano, M.D., PhD., Chair in Neuromodulation and Multi-Disciplinary Care at the University Health Network (UHN) and UoT. Disclosure: Memorial Sloan Kettering (MSK): Dr. Tabar has financial interests related to BlueRock. MSK has institutional financial interests related to BlueRock. Note the foregoing institutional disclosure language is included because the referenced study relates to MSK technology licensed to BlueRock. University Health Network (UHN): UHN has institutional financial interests related to BlueRock. More information about the Phase I trial is available at clinicaltrials.gov (NCT04802733). About Parkinson's disease Parkinson's disease is a progressive neurodegenerative disorder caused by the death of nerve cells in the brain, leading to decreased dopamine levels. At diagnosis, it is estimated that patients have already lost 50-80% of their dopaminergic neurons. The loss of these neurons leads to a progressive loss of motor function and symptoms such as tremors, muscle rigidity, and slowness of movement. Even with medication, the symptoms of Parkinson's disease can fluctuate during the course of the day. According to the Parkinson's Foundation, more than 10 million people worldwide suffer from Parkinson's disease, with approximately one million living in the United States. There is no cure and the effectiveness of current treatments decreases over time. About BlueRock Therapeutics LP BlueRock Therapeutics LP is a clinical stage cell therapy company focused on creating cellular medicines to reverse devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for patients suffering from neurological, cardiovascular, immunological, and ophthalmic diseases. Our lead clinical program, bemdaneprocel, (BRT-DA01) is in Phase I clinical trials for Parkinson's disease. We were founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to . Find more information at Follow us on LinkedIn/bluerocktx Find more information at Follow us on Facebook: Follow us on Twitter: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. SOURCE BlueRock Therapeutics

Phase 1Clinical ResultCell TherapyPhase 2

28 Aug 2023

·firstwordpharma.com

Bayer details early success with cell therapy for Parkinson's

Bayer and its BlueRock Therapeutics subsidiary on Monday detailed positive data from a Phase I trial of their investigational stem cell-derived therapy bemdaneprocel for the treatment of Parkinson's disease. Based on the results, the companies reiterated that preparations are underway for a Phase II study that is expected to begin enrolling patients in the first half 2024.In the open-label, non-randomised Phase I study, 12 subjects received surgical transplantation of one of two different dose levels of bemdaneprocel cells to the post-commissural putamen bilaterally. A one-year immunosuppression regimen was also given. Cohort A included five patients who received a dose of 0.9 million cells per putamen, while Cohort B had seven subjects who received 2.7 million cells per putamen. Safety and tolerability were assessed at one year, along with evidence of cell survival and motor effects.The detailed findings were presented at the International Congress of Parkinson's Disease and Movement Disorders. The study met the primary objective of safety and tolerability in all 12 participants across both cohorts, with no serious adverse events (SAEs) related to bemdaneprocel through one year. There were two SAEs reported that were unrelated to bemdaneprocel, with one being a seizure attributed to the surgical procedure, although the companies said both SAEs resolved without sequelae. They also noted that 18F-DOPA positron emission tomography (PET) scans showed evidence of cell survival and engraftment in both low- and high-dose cohorts.Longer time with well-controlled symptomsMeanwhile, secondary exploratory endpoints improved in both cohorts, with high-dose participants showing greater benefit, based on a pair of tools used to assess Parkinson's severity in motor symptoms. Within the high dose-cohort, the one-year evaluation of bemdaneprocel's impact using MDS-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) while in the OFF-medication state indicated a decline of 13 points compared to baseline. In the low-dose cohort, a reduction of 7.6 points was observed.Using the Hauser Diary, those in the high-dose cohort showed an improvement of 2.16 hours in time spent in the ON state without troubling dyskinesia, compared with baseline after one year, while time spent in the OFF state showed a corresponding decrease of 1.91 hours. Meanwhile, the low-dose cohort showed an improvement of 0.72 hours in the ON state without troubling dyskinesia time, compared with baseline, and a corresponding decrease of 0.75 hours in OFF state time."The positive outcome of this Phase I clinical trial is a clear step forward," remarked Christian Rommel, Bayer's head of drug R&D. Bemdaneprocel, also known as BRT-DA01, is designed to replace dopaminergic neuron precursors that are lost in Parkinson's patients. The neuron precursors are surgically implanted into the brain to restore neural networks destroyed by the disease.

Clinical ResultPhase 1Cell Therapy

100 Deals associated with FLUORODOPA F-18

External Link

KEGG	Wiki	ATC	Drug Bank
-	FLUORODOPA F-18	V09IX	DB13848

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diagnostic agents	CH	Novartis Pharma AG	01 Nov 2016
Parkinsonian Disorders	CH	Novartis Pharma AG	01 Nov 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple System Atrophy	Phase 3	CN	HTA Co., Ltd.	27 Dec 2024
Parkinson Disease	Phase 3	CN	HTA Co., Ltd.	27 Dec 2024
Supranuclear Palsy, Progressive	Phase 3	CN	HTA Co., Ltd.	27 Dec 2024
Tremor	Phase 3	CN	HTA Co., Ltd.	27 Dec 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03778294 (Pubmed \| Lancet Oncol)	Phase 2	Glioblastoma	43	Hypofractionated Proton Beam Therapy + Temozolomide	mijvrwfckv(itjcvrodxi) = gbrtufjzhn libtdkjygo (scxdvsrjnk ) View more	Positive	01 Dec 2024
EANM2024	Not Applicable	Neuroblastoma	10	123I-MIBGF-Dopa (123I-MIBG scintigraphy)	xkdwnrnees(mdumpjptnu) = yatzwajnch dlsqfeqhmz (grhwrsqbvd ) View more	Positive	27 Sep 2024
NCT03778294 (CTgov)	Phase 2	Glioblastoma	43	Proton Beam Radiation Therapy+Computed Tomography+Temozolomide	tyvncldyww(thbmyacrtc) = tudbaqmtjv dzrvpvgnyp (jtcpczhgif, jmjjmltsag - ovubfrffzu) View more	-	14 Nov 2023
Phase II study (SNO2023)	Phase 2	Glioblastoma 18F-DOPA	39	18F-DOPA (GTV ≤ 65 cc)	dmnkiykctz(xrvpuwtvpy) = omkxraxcnn ofiuarnjrg (iitaxejonb ) View more	Positive	10 Nov 2023
SAT555 (ENDO2023)	Not Applicable	Multiple Endocrine Neoplasia Type 2b \| Thyroid Cancer, Medullary	26	68 Ga-DOTATATE PET/CT	vfmckmucdq(lbihxwmhih) = mqbygrxqji luhocjgqub (rqzzqamchi ) View more	-	05 Oct 2023
SAT555 (ENDO2023)	Not Applicable		26	18 F-DOPA18 F-FDGA (18 F-FDG PET/CT)	vfmckmucdq(lbihxwmhih) = scukgfogml luhocjgqub (rqzzqamchi ) View more	-	05 Oct 2023
NCT03778294 (ASCO2023) Manual	Phase 2	Glioblastoma First line MGMT	39	18F-DOPA concurrent/adjuvant temozolomide	wbcmphqzfc(grcicvjgft) = lpblgufjrk iaufhrevax (opzcbzdmng ) Met View more	Positive	31 May 2023
NCT03778294 (ASCO2023) Manual	Phase 2	Glioblastoma First line MGMT	39	18F-DOPA concurrent/adjuvant temozolomide (MGMT methylation)	wbcmphqzfc(grcicvjgft) = ktynjqoxlg iaufhrevax (opzcbzdmng ) Met View more	Positive	31 May 2023
EANM2022	Not Applicable	Brain Cancer	55	18F-FDOPA (Primary Tumors)	rjbjilrrsh(fkflqbfqtd) = zqawsidxvc fnhlvwklmj (ivzfrkdreu ) View more	-	22 Sep 2022
EANM2022	Not Applicable	Brain Cancer	55	18F-FDOPA (Metastasis Tumors)	rjbjilrrsh(fkflqbfqtd) = uhcovpdiod fnhlvwklmj (ivzfrkdreu ) View more	-	22 Sep 2022
SNMMI2022	Not Applicable	Multiple Endocrine Neoplasia Type 2a	-	68Ga-DOTATATE PET/CT	tvaetbaqwk(apttjjgmot) = xxvejsffab qsxrvxmery (jrkzccmapi, 51.9 - 95.7)	-	08 Aug 2022
SNMMI2022	Not Applicable	Pheochromocytoma	-	68Ga-DOTATATE PET/CT	glwzbzgoox(qcunhfixeh) = zkxuddzwrr igwuzwaikc (bdbfgcbrjj, 21.2 - 86.3)	-	08 Aug 2022
SNMMI2022	Not Applicable	Brain metastases	-	18F-FDOPA PET (FDOPA PET/MRI)	klfpdibpjv(enpxnxsulq) = gztlmtvehu cavpqfrddl (jajgvsxnza ) View more	-	08 Aug 2022

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