PT  - JOURNAL ARTICLE
AU  - Sah, Bert-Ram
AU  - Burger, Irene A.
AU  - Schibli, Roger
AU  - Friebe, Matthias
AU  - Dinkelborg, Ludger
AU  - Graham, Keith
AU  - Borkowski, Sandra
AU  - Bacher-Stier, Claudia
AU  - Valencia, Ray
AU  - Srinivasan, Ananth
AU  - Hany, Thomas F.
AU  - Mu, Linjing
AU  - Wild, Peter J.
AU  - Schaefer, Niklaus G.
TI  - Dosimetry and First Clinical Evaluation of the New <sup>18</sup>F-Radiolabeled Bombesin Analogue BAY 864367 in Patients with Prostate Cancer
AID  - 10.2967/jnumed.114.147116
DP  - 2015 Mar 01
TA  - Journal of Nuclear Medicine
PG  - 372--378
VI  - 56
IP  - 3
4099  - http://jnm.snmjournals.org/content/56/3/372.short
4100  - http://jnm.snmjournals.org/content/56/3/372.full
SO  - J Nucl Med2015 Mar 01; 56
AB  - 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 18F-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 18F-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 18F-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.