PT - JOURNAL ARTICLE AU - David Alexoff AU - Robert Doot AU - Daniel Pryma AU - Erin Schubert AU - Zehui Wu AU - Zhihao Zha AU - Seok Choi AU - Karl Ploessl AU - sharon Lee AU - Christina Kao AU - Lin Zhu AU - David Mankoff AU - Hank Kung TI - Preliminary kinetic analysis of [<sup>68</sup>Ga]P15-041, a novel <sup>68</sup>Ga labeled bisphosphonate, from first-in-human studies DP - 2017 May 01 TA - Journal of Nuclear Medicine PG - 388--388 VI - 58 IP - supplement 1 4099 - http://jnm.snmjournals.org/content/58/supplement_1/388.short 4100 - http://jnm.snmjournals.org/content/58/supplement_1/388.full SO - J Nucl Med2017 May 01; 58 AB - 388Objectives: [68Ga]P15-041 (HBED-CC-BP) is a novel radiotracer in Phase 0/I clinical trials to evaluate its use as a Positron Emission Tomography (PET) tracer for imaging bone metastases in prostate cancer. Region of interest analysis (ROI) of the kinetics of HBED-CC-BP was carried out to determine its feasibility for use as a bone imaging agent.Methods: HBED-CC-BP was prepared by reacting 68GaC3 eluted from a 1110 MBq (30 mCi) 68Ge/68Ga generator (ITG) followed by purification by solid phase extraction. Approximately 100 - 370 Mbq was injected into patients with confirmed prostate cancer with known or suspected metastatic disease. For patients with a positive clinical bone scan, data was collected on a Philips Ingenuity PET/CT from time of injection to 60 minutes over a field of view determined by results from a clinical bone scan and subjected to ROI analysis. Skull-base to mid-thigh scans were conducted at 90 and 180 minutes post injection. Data analysis was performed using PMOD v.3.7 (PMOD Technologies LLC). Peak standard uptake values (SUVp) were determined according to Wahl (JNM 2009; 50:122S-50S) and Vanderhoek (JNM 2012; 53:4-11) using 1 cm3 volume spheres drawn on bone lesions, normal bone and the blood pool if available. Time activity curves were generated using PMOD.Results: HBED-CC-BP accumulated in known bone lesions and cleared rapidly from blood, soft tissue and normal bone. In a representative patient with tumors in the superior pubic ramus (Tumor-sPR) and iliac crest (Tumor-IC), tumor to normal bone ratios of 4 - 6 are reached in less than 30 minutes and climbed to 6 - 8 at times greater than 90 minutes. SUVp = 18, 13 and 2 for Tumor-sPR, Tumor-IC and normal bone respectively.Conclusion: [68Ga]P15-041’s uptake and clearance characteristics in patients with confirmed bone metastases support its continued development as a PET-based bone imaging agent that does not require cyclotron infrastructure for manufacturing and distribution. Research Support: N/A