Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Start Date01 Oct 2024

Sponsor / Collaborator

Blue Earth Diagnostics Ltd.Startup

[+1]

NCT06617481 / RecruitingPhase 2IIT

RhPSMA-7.3(18F)-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence

Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer.
The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.

Start Date20 Sep 2024

Sponsor / Collaborator

AdventHealth Waterman

[+1]

NCT06055790 / RecruitingPhase 2IIT

Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis

The goal of this diagnostic intervention clinical trial is to compare 18F-Fluciclovine uptake within brain lesions over 60 minutes compared with standard of care positive histology confirmation or confirmation MRI images. The main questions it aims to answer are:
1. What are the dynamics of 18F-Fluciclovine update within a non-treated metastatic brain lesion over 60 minutes?
2. What are the dynamics of 18F-fluciclovine update within recently treated metastatic brain lesions?
3. What is the potential use of 18F-Fluciclovine in delineating true local progression from radionecrosis in patients with clinical uncertainty of indeterminate MRI?
Participants will undergo an 18F-fluciclovine head PET/CT scan prior to treatment for brain metastatic lesion(s). The study will characterize uptake dynamic PET images over 60 minutes. Uptake within the lesions and the benign brain parenchyma will be plotted on a time activity curve for 60 mins. Patients will undergo a second 18F-fluciclovine PET/CT to evaluate 18F-fluciclovine uptake in treated lesions over 60 minutes. This will be offered concurrently with the post-procedure standard of care (SOC) MRI to evaluate post-treatment changes. Uptake within the lesions and the benign brain parenchyma will be plotted on a 60 min time activity curve. Results will be compared to the pre-treatment baseline images. A third 18F-fluciclovine PET/CT will be offered to evaluate post radiation changes necrosis from recurrence, for up to 10 patients in our cohort who are under clinical surveillance (up to three years surveillance) and developed MRI evidence of either true progression or radionecrosis with clinical uncertainty after stereotactic radiosurgery. The initial 18F-fluciclovine PET/CT will serve as a baseline PET/CT scan. This will be compared to post procedural histological confirmation.

Start Date10 Sep 2024

Sponsor / Collaborator

University of Arizona

[+1]

100 Clinical Results associated with Bracco Imaging SpA

0 Patents (Medical) associated with Bracco Imaging SpA

Literatures (Medical) associated with Bracco Imaging SpA

01 Aug 2024·Journal of Nuclear Medicine

Interreader and Intrareader Reproducibility of¹⁸F-Flotufolastat Image Interpretation in Patients with Newly Diagnosed or Recurrent Prostate Cancer: Data from Two Phase 3 Prospective Multicenter Studies

Article

Author: Yoo, Don ; Schuster, David M ; Esposito, Giuseppe ; Davis, Phillip ; Miller, Matthew P ; Zukotynski, Katherine ; Chau, Albert ; Chapin, Brian F ; Ravizzini, Gregory C ; Ulaner, Gary A ; Penny, Ross ; Kuo, Phillip H

Interreader and intrareader reproducibility of ¹⁸F-flotufolastat PET/CT scans in newly diagnosed and recurrent prostate cancer patients was assessed from masked image evaluations from two phase 3 studies. Methods: ¹⁸F-flotufolastat PET/CT images of newly diagnosed (n = 352) or recurrent (n = 389) patients were evaluated by 3 masked readers. Cohen κ was used to assess pairwise patient- and region-level interreader agreement. Agreement among all readers was assessed using Fleiss κ. Intrareader agreement between the first and repeat read (20% of images, ≥4 wk later) was assessed using Cohen κ. Results: Pairwise interreader agreement was 95% or better (newly diagnosed) and 75% or better (recurrent). The κ coefficients were impacted by the high-agreement-low-κ paradox: Cohen κ ranged from not estimable to 0.55, whereas Fleiss κ was 0.50 (newly diagnosed) and 0.41 (recurrent). Agreement was highest in the prostate of newly diagnosed patients (≥95%) and in the pelvic lymph nodes in recurrent patients (≥87%). Intrareader agreement was 86% or better across both populations. Conclusion: ¹⁸F-flotufolastat PET/CT images can be reliably interpreted, with a high degree of inter- and intrareader agreement.

01 Jul 2024·Journal of Nuclear Medicine

True-Positive¹⁸F-Flotufolastat Lesions in Patients with Prostate Cancer Recurrence with Baseline-Negative Conventional Imaging: Results from the Prospective, Phase 3, Multicenter SPOTLIGHT Study

Article

Author: Hermsen, Rick ; Chau, Albert ; Fleming, Mark T ; Davis, Phillip ; Chapin, Brian F ; Purysko, Andrei S ; Schuster, David M

¹⁸F-rhPSMA-7.3 (¹⁸F-flotufolastat) is a high-affinity prostate-specific membrane antigen-targeted diagnostic radiopharmaceutical for PET imaging in patients with prostate cancer. Here, we report findings from the SPOTLIGHT study (NCT04186845), assessing the performance of ¹⁸F-flotufolastat PET/CT for identifying prostate-specific membrane antigen-positive lesions confirmed by standard of truth (SoT) in men with biochemical recurrence of prostate cancer and negative conventional imaging at baseline. Methods: Men with biochemical recurrence received 296 MBq of ¹⁸F-flotufolastat intravenously and then underwent PET/CT 50-70 min later. ¹⁸F-flotufolastat PET/CT findings were evaluated by 3 masked central readers and verified using histopathology or follow-up confirmatory imaging (CT, MRI, bone scan, or ¹⁸F-fluciclovine PET/CT) as the SoT. The present analysis evaluated all patients who had negative conventional imaging at baseline, underwent ¹⁸F-flotufolastat PET/CT, and had SoT verification by histopathology or follow-up confirmatory imaging to report detection rate (DR), which is the number of patients with at least 1 PET-positive lesion, divided by the number of evaluable patients, and verified DR (VDR), which is the proportion of patients with at least 1 true-positive lesion as verified by SoT, of all patients scanned (PET-positive and PET-negative scans). DR and VDR were calculated and stratified according to prior therapy. Majority read data (agreement between ≥2 readers) are reported. Results: In total, 171 patients with negative baseline conventional imaging and SoT by histopathology or post-PET confirmatory imaging were evaluated. By majority read, the overall ¹⁸F-flotufolastat DR among these patients was 95% (163/171; 95% CI, 91.0%-98.0%), and 110 of 171 of these patients had at least 1 true-positive lesion identified (VDR, 64%; 95% CI, 56.7%-71.5%). In the postprostatectomy group (133/171), 8.3% of patients had at least 1 true-positive lesion in the prostate bed, 28% in pelvic lymph nodes, and 35% in other sites. Among those who had received radiotherapy (36/171), 50% of patients had true-positive detections in the prostate, 8.3% in pelvic lymph nodes, and 36% in other sites. Conclusion: ¹⁸F-flotufolastat frequently identified true-positive prostate cancer lesions in patients with negative conventional imaging. ¹⁸F-flotufolastat may help to better define sites of disease recurrence and inform salvage therapy decisions than does conventional imaging, potentially leading to improved outcomes.

01 Feb 2024·Molecular Imaging and Biology

Quantitative and Qualitative Assessment of Urinary Activity of 18F-Flotufolastat-PET/CT in Patients with Prostate Cancer: a Post Hoc Analysis of the LIGHTHOUSE and SPOTLIGHT Studies

Article

Author: Postema, Ernst J ; Penny, Ross ; Kuo, Phillip H ; Hermsen, Rick

AbstractPurposeTo evaluate the impact of urinary activity on interpretation of 18F-flotufolastat (18F-rhPSMA-7.3) PET/CT, we conducted a post hoc qualitative and quantitative analysis of scans acquired in two phase 3 studies of 18F-flotufolastat.ProceduresNewly diagnosed or recurrent prostate cancer patients enrolled in LIGHTHOUSE (NCT04186819) or SPOTLIGHT (NCT04186845), respectively, underwent PET/CT 50–70 min after intravenous administration of 296 MBq 18F-flotufolastat. For the present analysis, 718 18F-flotufolastat scans (352 from LIGHTHOUSE and 366 from SPOTLIGHT) were re-evaluated by three board-certified nuclear medicine physicians. Reader 1 performed a quantitative assessment (SUVmax and SUVmean) of bladder activity in a circular region-of-interest over the maximum diameter of bladder activity in the transverse plane. All three readers qualitatively assessed the impact of any urinary activity in the bladder on image interpretation using a three-point scale (0 = no/minimal visible urinary activity, 1 = urinary activity visible but distinction between urine and disease possible and 2 = assessment inhibited by urinary activity) and the presence/absence of ureteric activity and halo artifacts.ResultsIn total, 712/718 scans were evaluable. Reasons for exclusion were cystectomy, renal failure, or urinary catheter in situ (n = 2 each). The median bladder SUVmax and SUVmean were 17.1 and 12.5, respectively. By majority read, 682/712 (96%) patients had either no urinary activity (score = 0) or visible activity that could be distinguished from disease uptake (score = 1). In the minority of patients (24, 3.4%) where urinary activity did impact assessment (score = 2), the median bladder SUVmean was higher (20.5) than those scored 0 (3.8) or 1 (14.0). Ureteric activity was absent in 401 (56%) patients. Halo artifacts were observed in only two (0.3%) patients (majority read).Conclusions18F-Flotufolastat urinary activity did not influence disease assessment for the majority of patients. While this study was not designed as a head-to-head comparison, the median bladder SUVs are lower than previously reported values for other renally cleared PSMA-PET radiopharmaceuticals.

News (Medical) associated with Bracco Imaging SpA

30 Oct 2024

·www.prnewswire.com

Blue Earth Therapeutics Ltd announces completion of $76.5M Series A financing to accelerate development of next generation targeted radioligand therapies

Several external investors, including Soleus Capital and Sands Capital Management, join with initial investor Bracco Imaging S.p.A. in the financing Resources support Phase 2 studies for Lutetium (177Lu) rhPSMA-10.1 and Actinium (225Ac) rhPSMA-10.1, and development of differentiating data compared to 1st generation prostate cancer radioligand therapies OXFORD, United Kingdom, Oct. 30, 2024 /PRNewswire/ -- Blue Earth Therapeutics Ltd, an emerging leader in the development of therapeutic radiopharmaceuticals, today announced closing of a $76.5M Series A financing. The round was led by Soleus Capital and co-led by Sands Capital Management with existing investor Bracco Imaging SpA also participating. Woodline Partners and PBM Capital also joined in the financing as new institutional investors. The new funding comes from a broad spectrum of experienced biotech investors and enables Blue Earth Therapeutics to further advance its clinical stage PSMA-targeted radioligand therapies. "With the new investors and the team we have assembled, we now have a great mix of expertise and the resources to further our mission to develop radioligand therapies with the potential to improve patient outcomes by delivering high radiation doses to tumours without compromising on normal organ safety," said David Gauden, Blue Earth Therapeutics CEO. "With our recent announcement on completion of the Phase 1 clinical trial, we are making excellent progress on both our beta emitter Lutetium (177Lu) rhPSMA-10.1 and alpha emitter Actinium (225Ac) rhPSMA-10.1 agents and look forward to sharing further progress updates." "The establishment of PSMA-targeted radiopharmaceuticals as a class of therapy in prostate cancer represents a huge opportunity to improve outcomes for prostate cancer patients. Our new investors share our strong belief that Blue Earth Therapeutics' radiohybrid agents could be a significant improvement over currently approved treatment options," said Fulvio Renoldi Bracco, CEO of Bracco Imaging SpA. "We have observed the rapid acceptance of Pluvicto® as the first PSMA-targeted radioligand therapy for the treatment of prostate cancer, and at the same time see opportunities to do better," said David Canner, partner at Soleus Capital. "The early data the company has developed supports differentiation and gives us confidence to invest in the Blue Earth team. We look forward to advancing Blue Earth Therapeutics' compounds to later stage trials." David Canner from Soleus Capital and Michael Ginder from Sands Capital Management are joining the Board of Directors alongside representatives from Bracco Imaging SpA and experienced industry CEO David Gauden. About Radiohybrid Prostate‐Specific Membrane Antigen (rhPSMA) rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate‐Specific Membrane Antigen‐targeted receptor ligand. It is attached to two labelling moieties which may be radiolabeled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. About Blue Earth Therapeutics Blue Earth Therapeutics is a clinical stage company dedicated to advancing next generation targeted radiotherapeutics to treat patients who have cancer and has been incubated within the Bracco family of companies. With proven management expertise across the spectrum of radiopharmaceutical and oncology drug development, as well as biotechnology start‐up experience, the Company aims to innovate and improve upon current technologies and rapidly advance new targeted therapies for serious diseases. Blue Earth Therapeutics has an emerging pipeline initially focused on prostate cancer. For more information, please visit: . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world‐leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X‐ray imaging (including Computed Tomography‐CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose‐management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting‐edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: . Contacts: For Blue Earth Therapeutics Robert Dann Vice President, Strategy & Planning (617) 631-0234 [email protected] Media Edelman Inc. Amanda Lazaro (M) +1 617 775-1306 [email protected] SOURCE Blue Earth Therapeutics Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AcquisitionLicense out/inRadiation Therapy

30 Oct 2024

·endpts.com

Blue Earth Therapeutics snags $76M for both alpha and beta radiotherapies

The radiopharma field continues to buzz with private financings and more clinical-stage programs. The latest is Oxford, UK-based Blue Earth Therapeutics, which unveiled a $76.5 million Series A on Wednesday morning to bring its lutetium-based radioligand therapy into Phase 2 and its actinium-based asset into Phase 1. Both of those trials will begin in early 2025, CEO David Gauden told Endpoints News . The funding adds to a steady drumbeat of investor and pharma interest in the field. Alpha-9 Oncology bagged a $175 million Series C last week, the same amount that Aktis Oncology secured in a Series B last month. Gauden said the company will have key clinical data in about 12 to 18 months, at which point it could entertain pharma partnerships, another private funding round or an IPO if the markets are right. Industry interest is certainly there. Lilly, Novartis and Bristol Myers have all made radiopharma deals in the past 12 months. But a few other big pharmas haven’t “taken the plunge,” Gauden said, meaning there could be even more dealmaking activity in the years to come. Blue Earth seeks to make better PSMA-targeted radiopharmaceuticals than the first generation, which Novartis broke open with Pluvicto, Gauden said. The company hopes to double the amount of radiation delivered to prostate cancer lesions without compromising safety and side effects on normal organs, he added. Blue Earth works with external manufacturers, and it has three partners that can make drug product with access to about half a dozen suppliers for lutetium, Gauden said. Actinium 225-based radiopharmaceuticals have run into some supply constraints. Gauden said Blue Earth has enough for its upcoming Phase 1 and that the actinium supply chain should be where lutetium is today in about three to four years. The startup will continue to have “some shared activities and resources” with its sister company Blue Earth Diagnostics for about another year, Gauden said, but they’re “largely independent” at this point. Gauden became CEO of the therapeutics company in July after serving in the same post at the diagnostics business, which has FDA-approved imaging agents . Both are backed by Milan-based Bracco Imaging. In addition to Bracco, Blue Earth Therapeutics’ investors also include Soleus Capital, Sands Capital Management, Woodline Partners and PBM Capital.

Executive Change

16 Oct 2024

·www.prnewswire.com

Bracco Diagnostics Inc. and Subtle Medical Announce FDA Clearance of AiMIFY™ Software for Enhanced MRI

MONROE TOWNSHIP, N.J., Oct. 16, 2024 /PRNewswire/ -- Bracco Diagnostics Inc., a U.S. subsidiary of Bracco Imaging S.p.A, one of the world's leading companies in the diagnostic imaging business, and Subtle Medical, Inc., a pioneering innovator in artificial intelligence (AI)-powered image acquisition, are thrilled to announce that their collaborative AI-powered software, AiMIFY™, has received FDA clearance as a Class II software as a medical device (SaMD) for magnetic resonance imaging (MRI) of the brain. This groundbreaking software, exclusively from Bracco and Subtle Medical, is designed to significantly enhance MRI of the brain, particularly for detecting small and poorly enhanced lesions. "This FDA clearance marks a significant milestone for our innovative product, showcasing its potential to transform MRI," said Fulvio Renoldi Bracco, Vice Chairman & Chief Executive Officer of Bracco Imaging S.p.A. "By integrating Bracco's expertise in contrast imaging with Subtle Medical's cutting-edge deep-learning technology, we are poised to redefine diagnostic precision and efficiency, setting new standards in the field for the ultimate benefit of the patients." AiMIFY™ leverages advanced AI technology to amplify the contrast enhancement of brain MR images up to two times the level obtained with a labeled dose of gadolinium-based contrast agents (GBCAs). This enhancement provides radiologists and neuroradiologists with clearer, more detailed images, improving the visibility of small and large lesions compared to standard post-contrast images. The software's effectiveness has been validated across diverse test data, including various patient demographics, pathologies, lesion sizes, image scanner vendors, MRI sequences, and acquisition orientations. "We partnered with Bracco to unlock the potential that AI brings to medical imaging," said Ajit Shankaranarayanan, PhD, Chief Product Officer at Subtle Medical. "The FDA clearance represents a significant milestone for both companies, as we join forces to empower radiological professionals and improve outcomes for patients worldwide with this innovative AI-powered medical imaging solution." Bracco and Subtle will participate in the 110th Radiological Society of North America's (RSNA) Scientific Assembly and Annual Meeting Dec. 1-5, 2024 in Chicago. To learn more, visit the Bracco booth #3300 and the Subtle Medical booth #4739 in the South Hall, Level 3. Additional information about RSNA Technical Exhibits can be found here: AiMIFY is manufactured for Bracco Diagnostics Inc. by Subtle Medical Inc. – Menlo Park, CA, USA 94025 AiMIFY is a trademark of Bracco Imaging S.p.A. For additional information about Bracco's products, and for full prescribing information, please visit . About Bracco Imaging Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has 3,800 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. Discover Bracco at About Subtle Medical Subtle Medical is a global leader in AI-powered technology for faster, safer, and smarter medical imaging. The company's cutting-edge solutions for faster imaging optimize radiology workflows, improving productivity and patient experience. Subtle Medical has been recognized as a CB Insights GenAI 50 company and has been named to the CB Insights Top AI 100 and Digital Health 150 lists multiple times. By harnessing the power of artificial intelligence, Subtle Medical is transforming the future of healthcare. For more information, please visit subtlemedical.com or email [email protected]. Media Contacts: Bracco Diagnostics Inc. Media Relations (USA) Kimberly Gerweck Senior Compliance and Communications Manager [email protected] D: +1 609-524-2777 Subtle Medical Josh Gurewitz Chief Commercial Officer [email protected] D: +1 925-922-2615 SOURCE Bracco Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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100 Deals associated with Bracco Imaging SpA

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Pipeline Snapshot as of 05 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Flotufolastat F-18 ( PSMA )	Prostatic Cancer More	Approved
Fluciclovine 18F ( KLK3 )	Prostatic Cancer More	Approved
Gadopiclenol	Diagnostic agents More	Approved
Dimeric gadolinium complex (Bracco)	Contrast agents More	Preclinical
FAP-targeted technology(Blue Earth Diagnostics)	Solid tumor More	Preclinical

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