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.
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Authors | Bert-Ram Sah, Irene A Burger, Roger Schibli, Matthias Friebe, Ludger Dinkelborg, Keith Graham, Sandra Borkowski, Claudia Bacher-Stier, Ray Valencia, Ananth Srinivasan, Thomas F Hany, Linjing Mu, Peter J Wild, Niklaus G Schaefer |
Journal | Journal of nuclear medicine : official publication, Society of Nuclear Medicine
(J Nucl Med)
Vol. 56
Issue 3
Pg. 372-8
(Mar 2015)
ISSN: 1535-5667 [Electronic] United States |
PMID | 25678494
(Publication Type: Journal Article)
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Copyright | © 2015 by the Society of Nuclear Medicine and Molecular Imaging, Inc. |
Chemical References |
- BAY 86-4367
- Fluorine Radioisotopes
- Radiopharmaceuticals
- Gastrin-Releasing Peptide
- Prostate-Specific Antigen
- Bombesin
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Topics |
- Administration, Intravenous
- Aged
- Algorithms
- Biopsy
- Bombesin
(analogs & derivatives)
- Fluorine Radioisotopes
- Gastrin-Releasing Peptide
(chemistry)
- Humans
- Male
- Middle Aged
- Neoplasm Recurrence, Local
(diagnostic imaging)
- Positron-Emission Tomography
- Prostate-Specific Antigen
(metabolism)
- Prostatic Neoplasms
(diagnostic imaging)
- Radiometry
(methods)
- Radiopharmaceuticals
- Software
- Tomography, X-Ray Computed
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