NCT02424513

A Study of Positron Emission Tomography (PET) With [89]Zr-Df-IAb2M in Patients With High-risk Prostate Cancer

A Phase 2 Study of Positron Emission Tomography (PET) With [89]Zr-Df-IAb2M in Patients With High-risk Prostate Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ImaginAb, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, open-label, non-randomized study evaluating the ability of \[89\]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by pathology.

Detailed description

IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody") chelated with Desferroxamine and radiolabeled with \[89\]Zr. \[89Zr\]-Df-IAB2M targets the extracellular domain of Prostate Membrane Specific Antigen (PSMA) expressed on most primary and metastatic prostate cancer lesions. This is a phase 2, prospective, multi-center, open-label, non-randomized study evaluating the ability of \[89\]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by pathology in patients with biopsy-proven prostate cancer thought to be candidates for radical prostatectomy and pelvic lymph node dissection who are at high-risk for pelvic lymph node metastasis. These patients may have identified lymphadenopathy on conventional imaging but are considered eligible if still judged to be candidates for radical prostatectomy and lymph node dissection.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	[89Zr]Df-IAB2M	A single intravenous infusion of 2.5 mCi of \[89Zr\]Df-IAB2M in a mass dose of 10 mg.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-04-23
• Last updated: 2015-06-02

Locations

1 site across 1 country: United States