Bert-Ram Sah1, Irene A Burger1, Roger Schibli2, Matthias Friebe3, Ludger Dinkelborg3, Keith Graham4, Sandra Borkowski4, Claudia Bacher-Stier4, Ray Valencia4, Ananth Srinivasan4, Thomas F Hany1, Linjing Mu1, Peter J Wild5, Niklaus G Schaefer6. 1. Division of Nuclear Medicine, Department of Medical Radiology, University Hospital of Zurich, Zurich, Switzerland. 2. Center for Radiopharmaceutical Science, Paul Scherrer Institute, Villigen PSI, Switzerland Department of Chemistry and Applied Biosciences of the Eidgenössische Technische Hochschule Zürich, Zurich, Switzerland. 3. Piramal, Molecular Imaging Division, Piramal Imaging GmbH, Berlin, Germany. 4. Bayer Healthcare, Global Drug Discovery, Berlin, Germany. 5. Department of Pathology, University Hospital of Zurich, Zurich, Switzerland; and. 6. Division of Nuclear Medicine, Department of Medical Radiology, University Hospital of Zurich, Zurich, Switzerland Division of Medical Oncology, Department of Internal Medicine, University Hospital of Zurich, Zurich, Switzerland niklaus.schaefer@usz.ch.
Abstract
UNLABELLED: The aim of this first-in-man study was to demonstrate the feasibility, safety, and tolerability, as well as provide dosimetric data and evaluate the imaging properties, of the bombesin analogue BAY 864367 for PET/CT in a small group of patients with primary and recurrent prostate cancer (PCa). METHODS: Ten patients with biopsy-proven PCa (5 with primary PCa and 5 with prostate-specific antigen recurrence after radical prostatectomy) were prospectively selected for this exploratory clinical trial with BAY 864367, a new (18)F-labeled bombesin analogue. PET scans were assessed at 6 time points, up to 110 min after intravenous administration of 302 ± 11 MBq of BAY 864367. Imaging results were compared with (18)F-fluorocholine PET/CT scans. Dosimetry was calculated using the OLINDA/EXM software. RESULTS: Three of 5 patients with primary disease showed positive tumor delineation in the prostate, and 2 of 5 patients with biochemical relapse showed a lesion suggestive of recurrence on the BAY 864367 scan. Tumor-to-background ratio averaged 12.9 ± 7.0. The ratio of malignant prostate tissue to normal prostate tissue was 4.4 ± 0.6 in 3 patients with tracer uptake in the primary PCa. Mean effective dose was 4.3 ± 0.3 mSv/patient (range, 3.7-4.9 mSv). CONCLUSION: BAY 864367, a novel (18)F-labeled bombesin tracer, was successfully investigated in a first-in-man clinical trial of PCa and showed favorable dosimetric values. Additionally, the application was safe and well tolerated. The tracer delineated tumors in a subset of patients, demonstrating the potential of gastrin-releasing-peptide receptor imaging.
UNLABELLED: The aim of this first-in-man study was to demonstrate the feasibility, safety, and tolerability, as well as provide dosimetric data and evaluate the imaging properties, of the bombesin analogue BAY 864367 for PET/CT in a small group of patients with primary and recurrent prostate cancer (PCa). METHODS: Ten patients with biopsy-proven PCa (5 with primary PCa and 5 with prostate-specific antigen recurrence after radical prostatectomy) were prospectively selected for this exploratory clinical trial with BAY 864367, a new (18)F-labeled bombesin analogue. PET scans were assessed at 6 time points, up to 110 min after intravenous administration of 302 ± 11 MBq of BAY 864367. Imaging results were compared with (18)F-fluorocholine PET/CT scans. Dosimetry was calculated using the OLINDA/EXM software. RESULTS: Three of 5 patients with primary disease showed positive tumor delineation in the prostate, and 2 of 5 patients with biochemical relapse showed a lesion suggestive of recurrence on the BAY 864367 scan. Tumor-to-background ratio averaged 12.9 ± 7.0. The ratio of malignant prostate tissue to normal prostate tissue was 4.4 ± 0.6 in 3 patients with tracer uptake in the primary PCa. Mean effective dose was 4.3 ± 0.3 mSv/patient (range, 3.7-4.9 mSv). CONCLUSION:BAY 864367, a novel (18)F-labeled bombesin tracer, was successfully investigated in a first-in-man clinical trial of PCa and showed favorable dosimetric values. Additionally, the application was safe and well tolerated. The tracer delineated tumors in a subset of patients, demonstrating the potential of gastrin-releasing-peptide receptor imaging.
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Authors: Steven P Rowe; Katarzyna J Macura; Esther Mena; Amanda L Blackford; Rosa Nadal; Emmanuel S Antonarakis; Mario Eisenberger; Michael Carducci; Hong Fan; Robert F Dannals; Ying Chen; Ronnie C Mease; Zsolt Szabo; Martin G Pomper; Steve Y Cho Journal: Mol Imaging Biol Date: 2016-06 Impact factor: 3.488
Authors: Gesche Wieser; Ilinca Popp; H Christian Rischke; Vanessa Drendel; Anca-Ligia Grosu; Mark Bartholomä; Wolfgang A Weber; Rosalba Mansi; Ulrich Wetterauer; Wolfgang Schultze-Seemann; Philipp T Meyer; Cordula Annette Jilg Journal: Eur J Nucl Med Mol Imaging Date: 2017-04-18 Impact factor: 9.236