Spots Global Cancer Trial Database for Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer

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Trial Identification

Brief Title: Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer

Official Title: A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic Prostate Cancer

Study ID: NCT01923727

Conditions

Metastatic Prostate Cancer

Interventions

[89Zr]Df-IAB2M

Study Description

Brief Summary: This is a Phase I/IIa study evaluating the safety and feasibility of \[89Zr\]Df-IAB2M as an immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the injection of \[89Zr\]Df-IAB2M PET tracer. Three different dosing levels will be explored. The purpose of the study is to demonstrate the safety of \[89Zr\]Df-IAB2M, ability to detect prostate cancer, and optimal time point and dose level for imaging.

Detailed Description: IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody"). Limited (Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and bone lesions in advanced metastatic prostate cancer.