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Biodistribution and Dosimetry of Serial PET Imaging With Ga-68 Labeled F(ab') 2- Trastuzumab

NCT00613847 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-10-26

No results posted yet for this study

Summary

The purpose of this study is to learn more about how a new study agent works inside the body. This study agent is a protein called 68Ga-F(ab')2-trastuzumab fragments (HERScan). This is a radioactive tracer that was developed at MSKCC to target the HER2 protein on cancer cells. By giving this tracer to patients whose cancers have the HER2 protein, we hope to be able to see the level of HER2 on the cancer cells using PET scanning.

Conditions

Interventions

RADIATION

PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab

Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.

RADIATION

PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab

Once safety and feasibility has been established in this group, then enrollment to the HER2 1+ cohort will commence. Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.

Sponsors & Collaborators

Principal Investigators

  • Jorge Carrasquillo, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00613847 on ClinicalTrials.gov