The goal of this study is to propose the first direct comparison of Ga-68-DOTATATE PET/CT or PET/MR and Ga-68-DOTATOC PET/CT in patients with meningioma.

Start Date01 Sep 2024

Sponsor / Collaborator

Weill Medical College of Cornell University

[+1]

CTR20233293 / RecruitingPhase 3

镓[68Ga]伊索曲肽用于生长抑素受体过表达的高分化胃肠胰神经内分泌瘤 PET/CT 诊断的前瞻性、单臂、盲态阅片、自身对照 III 期临床研究

[Translation] A prospective, single-arm, blinded, self-controlled phase III clinical study of gallium [68Ga] esotreotide for the PET/CT diagnosis of well-differentiated gastroenteropancreatic neuroendocrine tumors with somatostatin receptor overexpression

评价镓[68Ga]伊索曲肽用于高分化胃肠胰神经内分泌瘤PET/CT成像的诊断效能。

[Translation]

To evaluate the diagnostic efficacy of gallium [68Ga] esoprotreotide for PET/CT imaging of well-differentiated gastrointestinal and pancreatic neuroendocrine tumors.

Start Date22 Feb 2024

Sponsor / Collaborator

Tianjin Hengrui Pharmaceutical Co., Ltd

NCT06091748 / Not yet recruitingPhase 3

An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors

This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.

Start Date01 Nov 2023

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with 68Ga-Edotreotide

100 Translational Medicine associated with 68Ga-Edotreotide

100 Patents (Medical) associated with 68Ga-Edotreotide

254

Literatures (Medical) associated with 68Ga-Edotreotide

24 Jun 2024·EJNMMI reports

Increased [⁶⁸Ga]Ga-SST uptake in the uncinate pancreatic process in new digital PET/CT machine and potential association with clinical and histologic factors in NET patients.

Article

Author: Schaefer, Niklaus ; Sempoux, Christine ; Prior, John O ; Firsova, Maria ; Boughdad, Sarah ; Treglia, Giorgio ; Dromain, Clarisse

INTRODUCTIONA physiological increase in the uptake of [⁶⁸Ga]Ga-labeled somatostatin analogues ([⁶⁸Ga]Ga-SST) PET tracers has been reported in the uncinate pancreatic process (UP) and might be even higher in latest generation of PET/CT scanners and might be falsely interpreted as NET. We aimed to investigate the uptake of UP in a large population of NET patients who underwent [⁶⁸Ga]Ga-SST PET/CT with digital SiPM detectors. We also explored potential associations between UP uptake and various clinical, imaging, and pathological factors routinely assessed in NET patients.METHODSWe analyzed all consecutive NET patients from July 2018 to June 2022 in this retrospective, single-center study. All patients underwent a [⁶⁸Ga]Ga-SST PET/CT scan on a digital SiPM PET/CT scanner. On visual analysis, we distinguished between normal linear and homogenous UP uptake or abnormal if otherwise. We compared SUV_max/mean in patients with normal UP uptake to those with abnormal UP uptake with suspicious NET lesions on contrast-enhanced CT (ce-CT) and according to the site of the primary NET (pancreatic NET vs. other), patient gender (female vs. male) and tumor grade (grade 1-2 vs. 3) using a Mann-Whitney test. We also assessed the correlation between SUV_max/mean values in UP with patients' age, primary NET Ki-67 counting, and its SUV_max/mean, TLA and MTV values.RESULTSWe included 131 NET patients with a total of 34 [⁶⁸Ga]Ga-DOTATATE PET/CT and 113 [⁶⁸Ga]Ga-DOTATOC PET/CT scans. An abnormal UP uptake was seen in 32 patients with 65.7% of suspicious NET lesion or extrinsic compression on morphological imaging. Normal UP uptake SUV_max/mean were measured in 115 [⁶⁸Ga]Ga-SST scans (78.2%) with normal UP uptake and without suspicious lesion on morphological imaging. We found an average SUV_max of 12.3 ± 4.1 for [⁶⁸Ga]Ga-DOTATATE and 19.8 ± 9.8 g/ml for [⁶⁸Ga]Ga-DOTATOC, hence higher than those reported in the literature [SUVmax 5 ± 1.6 to 12.6 ± 2.2 g/ml] with significant difference with abnormal UP uptake and between both PET tracers (both p < 0.01). Significant results were a higher UP uptake on [⁶⁸Ga]Ga-DOTATOC in male patients (p = 0.02) and significant associations between UP uptake on [⁶⁸Ga]Ga-DOTATOC and SUV_max/mean of the primary tumor (ρ [0.337-0.363]; p [0.01-0.02]).CONCLUSIONWe confirmed a higher and very frequent UP uptake in latest SiPM-detector [⁶⁸Ga]Ga-SST PET/CT with an even higher uptake in patients that had [⁶⁸Ga]Ga-DOTATOC PET/CT. SUV_mean/max were significantly higher in abnormal UP uptake but there were overlaps with UP SUV values for both [⁶⁸Ga]Ga-SST and a correlation to morphological imaging is crucial. Besides, significant associations between UP uptake and SUV_mean/max of the primary NET as well as patients' gender were seen in the larger cohort of [⁶⁸Ga]Ga-DOTATOC patients suggesting that both physiological and pathological parameters could affect UP uptake.

17 May 2024·Archives of endocrinology and metabolism

Expression of somatostatin receptors in hemangioblastomas associated with von Hippel-Lindau disease as a novel diagnostic, therapeutic, and follow-up opportunity: A case report and literature review.

Review

Author: Brabo, Eloá Pereira ; Rafful, Patrícia Piazza ; Rosado-de-Castro, Paulo Henrique ; de Almeida, Sergio Altino ; Vieira Neto, Leonardo

Hemangioblastomas associated with von Hippel-Lindau (VHL) disease are frequently multiple and recur during prolonged follow-up. Currently, no systemic treatment is available for these tumors. Recent studies have shown the expression of somatostatin receptors in these types of hemangioblastomas. Notably, increased somatostatin receptor expression in a tumor, as determined by peptide-receptor radionuclide imaging, is a predictive factor of response to treatment with somatostatin analogs and peptide-receptor radionuclide therapy. The aim of this study was to describe the case of a patient with increased expression of somatostatin receptors in a suprasellar hemangioblastoma associated with VHL disease and conduct a literature review on somatostatin receptor expression in patients with VHL-associated hemangioblastomas. We describe herein the case of a 51-year-old man with VHL disease who had a suprasellar hemangioblastoma detected on magnetic resonance imaging. Peptide-receptor radionuclide imaging using gallium-68-DOTATOC (⁶⁸Ga-DOTATOC) identified increased expression of somatostatin receptors in the suprasellar hemangioblastoma, along with multiple pancreatic neuroendocrine tumors and bilateral pheochromocytomas. The patient was treated for 1 year with lanreotide, a somatostatin analog. A repeat ⁶⁸Ga-DOTATOC 1 year after starting lanreotide revealed decreased radiotracer uptake by the hemangioblastoma, consistent with a metabolic response. The presence of somatostatin receptors in hemangioblastomas associated with VHL disease is a novel finding. The decreased expression of these receptors after treatment with a somatostatin analog, as described in the present case, positions the somatostatin receptor as a new target for novel diagnostic, therapeutic, and follow-up opportunities in patients with VHL disease.

23 Apr 2024·JCEM Case Reports

Emerging Role of Gallium-68 DOTANOC PET/CT Guided Radiofrequency Ablation in the Treatment of Tumor-induced Osteomalacia

Author: Sharma, Jyoti ; Sharma, Gaurav Kant ; Jain, Tarun ; Kasliwal, Rajeev

AbstractTumor-induced osteomalacia (TIO) is a rare acquired form of hypophosphatemia that can be cured when the tumor responsible is completely removed. These tumors can be small and located in anatomically challenging areas, rendering surgery both risky and extensive. Radiofrequency ablation (RFA) has been explored as an effective treatment option for such tumors. We present a case of a 35-year-old man exhibiting clinical and biochemical features consistent with TIO. The culprit lesion was not detectable on the whole-body computed tomography (CT) scan. Gallium (Ga-68) DOTANOC positron emission tomography (PET)/CT showed increased uptake in the left acetabulum and magnetic resonance imaging (MRI) confirmed the location of the tumor. Given the risky anatomical location, we opted for less-invasive RFA. Following an unsuccessful attempt at CT-guided RFA of the lesion, we used real-time Ga-68 DOTANOC PET/CT guidance for precise imaging during the ablation procedure. Our patient achieved complete remission both clinically and biochemically after RFA. This response was also evident by the absence of tracer uptake in follow-up imaging. In conclusion, DOTANOC PET/CT–guided RFA can serve as a safe and effective treatment for patients with tumors causing TIO. This modality proves valuable when surgical resection is not a viable option.

News (Medical) associated with 68Ga-Edotreotide

06 Jun 2024

·firstwordpharma.com

Key radioisotope supplier ITM raises over $200M to fund pipeline, boost manufacturing

As radiopharmaceuticals continue their hot streak, one of the few players with a marketed product, ITM Isotope Technologies Munich, has pulled in additional funding to help advance its lead pipeline candidate. The firm has secured a new investment of €188 million ($204 million), led by previous backer Temasek, with participation from BlackRock, Qatar Investment Authority and ATHOS.ITM currently markets EndolucinBeta, which uses lutetium-177 (177Lu) for radiolabelling of other medicines, and TOCscan/Sogacin, which uses gallium (68Ga) edotreotide for diagnosing neuroendocrine tumours (NETs). While the two products are sold in a handful of European countries, ITM's pipeline has loftier ambitions and is stacked with a number of targeted radionuclide therapies based not only on 177Lu and 68Ga, but also on actinium-225 (225Ac), fluorine-18 and terbium-161.Phase III nearing completionIts lead asset, ITM-11 (177Lu-edotreotide), is nearing the end of Phase III testing in gastroenteropancreatic NETs (GEP-NETs). The late-stage COMPETE study is evaluating ITM-11 in patients with Grade 1 - 2 GEP-NETs, while the COMPOSE trial is for patients with well-differentiated high Grade 2 - 3 GEP-NETs. With this in mind, ITM will use some of the proceeds from the latest financing to “prepare commercial readiness” of ITM-11.“We have reached key milestones since our last financing round including advancing our pipeline with novel targets in multiple oncology indications,” remarked CEO Steffen Schuster. Almost exactly a year ago to the day, ITM announced a haul of €255 million – again led by Temasek – building on the €58 million it raised in 2022 and €114 million it secured in the prior year. Key supplier to NovartisAside from its internal pipeline, ITM recently launched a joint venture to produce 225Ac, while it has several supply agreements in place for 177Lu, including with Telix Pharmaceuticals and Endocyte, the latter now part of Novartis. In fact, the Swiss drugmaker is one of the key players in the radiopharmaceutical space, with its marketed products including Lutathera (177Lu dotatate) for GEP-NETs and the prostate cancer therapy Pluvicto (177Lu vipivotide tetraxetan). However, Novartis itself has faced production issues for Pluvicto, and only recently gained clearance for a new US radioligand manufacturing facility to help it keep up with demand.ITM plans to put some of the new funding toward ramping up its in-house manufacturing capacities for 177Lu and expand these to new radioisotopes including 225Ac. ITM said it will use the radioisotopes not only for its own pipeline, but also provide them to its global supply network. For related analysis, see Vital Signs: Mapping the slim pickings in radiopharmaceuticals.

Phase 3OligonucleotideIND

16 Apr 2024

·www.prnewswire.com

Evergreen Theragnostics Completes $26M Capital Raise to Advance Novel Radiopharmaceutical Pipeline into the Clinic, Prepare for First Commercial Product Launch, and Expand Industry-Leading CDMO Services

SPRINGFIELD, N.J., April 16, 2024 /PRNewswire/ -- Evergreen Theragnostics, Inc., a clinical-stage radiopharmaceutical company, today announced the successful completion of a $26M capital raise supported both by existing shareholders and new institutional investors, Petrichor and LIFTT. The financing advances Evergreen's novel discovery pipeline into clinical trials, supports commercialization of its diagnostic agent, and further expands CDMO capabilities to meet growing client demand. "We have been advancing our discovery pipeline and are excited to take the next step in development," commented James Cook, CEO. "As we continue to work with the FDA on approval of our Ga-68 DOTATOC diagnostic kit, this new funding will enable us to rapidly progress our novel theragnostic pair, EVG-321, into clinical trials. In addition, our CDMO business is continuing to build momentum as we bring on new customers and expand our efforts with existing ones. We appreciate the trust given to us by our existing and new shareholders in advancing our priorities." "We have tracked Evergreen since the company's inception and are excited to partner with James and his team as they bring best- and first-in-class candidates into the clinic, broaden their top-tier radiopharma drug discovery efforts, prepare for commercial launch of their diagnostic product, and further capitalize on the highly specialized expertise required to build and run a radiopharma CDMO," said Patrick Lally, Partner at Petrichor. Stefano Buono, chairman of LIFTT and founder and former CEO of Advanced Accelerator Applications (AAA) noted, "the radioligand therapy industry is advancing rapidly. Our investment in Evergreen Theragnostics deepens our commitment to this exciting area with a company that is well-positioned to succeed." Evergreen has established a lean and experienced team of scientific, medical, commercial, and operational leaders and employees to continue to develop our capabilities. Over the next months, Evergreen will continue to plan for the launch of our diagnostic agent Octevy™, subject to approval by the FDA. Evergreen Discovery also intends to begin registration enabling therapeutic and diagnostic clinical trials for Lutetium-177 (177Lu) EVG-321 and Gallium-68 (68Ga) EVG-321, a novel radiopharmaceutical theragnostic pair, which, if successful, could offer new hope to patients with small cell lung cancer. About Evergreen Theragnostics, Inc. Evergreen Theragnostics is focused on improving the available options for cancer patients using radiopharmaceuticals. The company is engaged in Contract Development and Manufacturing (CDMO) services as well as drug discovery and commercialization of proprietary products. Evergreen is headquartered in Springfield, NJ in a state-of-the-art GMP radiopharmaceutical facility. The company was founded in 2019 by a team that brings a strong track record in theragnostic radiopharmaceutical manufacturing and commercialization. For more information, please visit . About Petrichor Petrichor partners with world-class healthcare managers and businesses to provide customized investment structures and support. The Petrichor team has completed over 125 investments representing more than $6 billion in invested capital and has held over 55 board seats. Petrichor maintains a deep in-house understanding of healthcare products and services, including scientific, technical, and commercial expertise. This healthcare expertise, together with a breadth of experience investing across sectors, geographies, and capital structures, provides a unique combination to help build successful companies. For more information on Petrichor, please see or contact the firm at [email protected]. About LIFTT LIFTT is an Italian Venture Capital operating in every industry with a focus on deep-tech. To date it has raised €103,7M and completed 50 investments in innovative start-ups. While generating value for its shareholders, LIFTT supports the creation of businesses, development, employment, and economic growth, through the implementation of an ethical and transparent governance model. To learn more, please visit For further information, please contact: James Cook President & CEO [email protected] SOURCE Evergreen Theragnostics, Inc.

23 Jun 2023

·www.prnewswire.com

Jubilant Radiopharma and Evergreen Theragnostics Announce Collaboration for the Sale and Distribution of Neuroendocrine Tumor Diagnostic OCTEVY™, (Kit for Preparation of Ga 68 DOTATOC Injection), pending FDA approval in 2H 2023

YARDLEY, Pa., and SPRINGFIELD, N.J., June 23, 2023 /PRNewswire/ -- Jubilant Draximage Inc. (dba, Jubilant Radiopharma™), a Jubilant Pharma Company, through it's Radiopharmacy business division which maintains the second largest nuclear medicine pharmacy network in the US, and Evergreen Theragnostics, Inc., a radiopharmaceutical company focused on improving the available options for cancer patients, announced a new agreement for Jubilant's radiopharmacy business to prepare, sell, and distribute doses of OCTEVY™ (Kit for Preparation of Ga 68 DOTATOC Injection) to positron emission tomography (PET) customers across the US. OCTEVYTM is pending approval by the United States Food & Drug Administration (FDA), which is expected in 2H 2023. OCTEVY™ is currently under evaluation by the FDA as a potential radioactive diagnostic agent indicated for use with PET for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. If approved, OCTEVY™ can provide a new imaging option for healthcare providers to aid in the management of NETs in their patients. Under the terms of the agreement, upon regulatory approval, Jubilant will reconstitute, radiolabel, and deliver OCTEVY™ doses ordered by hospitals and independent PET imaging centers in the United States. _________________________________________________ About Neuroendocrine Tumors Neuroendocrine tumors (NETs) are a diverse set of cancers that originate in neuroendocrine cells, which are cells that carry messages from the nervous system to the endocrine system. Because neuroendocrine cells are located in many organs, NETs are often heterogeneous in their symptoms and therefore difficult to diagnose. The incidence of NETs are low, but are increasing, likely in part due to increased diagnosis of the disease. Once a patient has been identified as having a NET, they will often undergo a PET scan to localize and state the cancer, which will help the care team identify the best course of treatment. About OCTEVY™ OCTEVY™ (Kit for Preparation of Ga 68 DOTATOC Injection), is currently under evaluation by FDA as a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. OCTEVY™ is supplied as a 2-vial kit to radiopharmacies which allows for direct preparation of Ga 68 DOTATOC injection with the eluate of Gallium from an on-site generator at the radiopharmacy. OCTEVY™ is not currently approved by the FDA and is not yet available for sale in the United States. About Jubilant Radiopharmacy Business Jubilant's Radiopharmacy business is the second largest nuclear medicine pharmacy network in the United States, owns and operates 46 radiopharmacies across 21 states, offering an extensive portfolio of nuclear imaging products. Jubilant's radiopharmacy business only supply FDA approved, high quality radiopharmaceuticals. We provide highly customized customer solutions and exceptional service to our customers and the patients they serve. For more information, please visit About Evergreen Theragnostics Evergreen Theragnostics, headquartered in Springfield, NJ in a state-of-the-art GMP radiopharmaceutical facility, is focused on improving the available options for cancer patients using radiopharmaceuticals. Founded in 2019, the company is engaged in three core areas: CDMO, Products, and Drug Discovery. The CDMO business unit offers research and commercial scale, centralized production capacity for therapeutic and long-lived diagnostic products. The Products business unit develops and commercializes Evergreen-owned assets. Evergreen Discovery is focused on developing novel radiopharmaceuticals for cancer therapy, focusing on unprecedented and first-in-class radiopharmaceuticals. For more information, please visit . CONTACTS: Evergreen Theragnostics, Inc. James Cook Chief Executive Officer [email protected] Jubilant Radiopharma Renato Leite President [email protected] SOURCE Evergreen Theragnostics, Inc.

Diagnostic ReagentsClinical Study

100 Deals associated with 68Ga-Edotreotide

External Link

KEGG	Wiki	ATC	Drug Bank
-	68Ga-Edotreotide	V09IX	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neuroendocrine Tumors	US	UNIV IOWA HOSPS AND CLINICS PET IMAGING CENTER	21 Aug 2019
Gastro-Enteropancreatic Neuroendocrine Tumor	-	ITM Isotopen Technologien München AG	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	CN	Tianjin Hengrui Pharmaceutical Co., Ltd	22 Feb 2024
Endocarditis, Bacterial	Phase 1	-	-	01 Apr 2022
Carcinoid Tumor	Phase 1	US	-	01 Sep 2015
Neuroendocrine Tumors	Discovery	-	Montefiore Medical Center	16 May 2016
Medulloblastoma	Discovery	US	National Cancer Institute	01 Apr 2013
Neuroblastoma	Discovery	US	National Cancer Institute	01 Apr 2013
Somatostatinoma	Discovery	US	National Cancer Institute	01 Apr 2013
Glioma	Discovery	FI	Turku University Hospital	01 Oct 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01869725 (CTgov)	Phase 2	Somatostatinoma \| Neuroblastoma \| Medulloblastoma	68	contrast-enhanced magnetic resonance imaging+gallium Ga 68-edotreotide	srlkelbdlt(neotjaplmp) = qsibgdobno syldafqitg (ibgnztvdge, qpkpzhnejp - ckbdbimkus) View more	-	22 Sep 2021
NCT01619865 (CTgov)	Phase 1/2	Carcinoid Tumor \| Neuroblastoma \| Medulloblastoma \| Somatostatin Receptor-Positive Neuroendocrine Tumor	223	68Ga-DOTATOC PET/CT	snbsgpmszm(swtaxinnwg) = zemigktdbt hgrcykspob (uqugotksuj, lmymiqawty - wlytastemw) View more	-	02 Feb 2021
NCT03136328 (CTgov)	Phase 3	Neuroendocrine Tumors	11	68Ga-DOTATOC	atqhpexmlj(hlkbrhwgac) = bucmxaeada xymkhkfooa (hvttqhatsf, efrtxywuqq - bjfdqfmmkh) View more	-	30 Jan 2019

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