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

NCT01923727 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-02-13

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

[89Zr]Df-IAB2M

A single intravenous infusion of 5 mCi of \[89Zr\]Df-IAB2M in a mass dose of 10 mg, 20mg or 50mg.

Sponsors & Collaborators

  • ImaginAb, Inc.

    lead INDUSTRY

Principal Investigators

  • Neeta Pandit-Taskar, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-05-31
Completion
2016-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01923727 on ClinicalTrials.gov