Dosimetry and first clinical evaluation of the new 18F-radiolabeled bombesin analogue BAY 864367 in patients with prostate cancer.

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.

• 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)
• 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

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