MedTrace Logo

111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer

NCT01445054 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-03-11

No results posted yet for this study

Summary

Background:

* Some breast cancer cells have specific proteins (receptors) on their surface that make the tumor grow faster than normal cells. One of these receptors is called HER2/neu.
* An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the cancer cell.
* Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has been attached to a tiny amount of Herceptin.

Objectives:

-To see if Indium-Herceptin provides information about the characteristics of the breast cancer in women whose tumors express HER2/neu and those whose tumors do not.

Eligibility:

-Women 18 years or older with primary or metastatic breast cancer who have not received treatment with herceptin for at least 6 months before enrollment into the study.

Design:

* Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu status.
* Patients have a physical examination and review of medical records.
* Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma camera that detects the radioactivity in the Indium-Herceptin.
* Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine the best time to image after injection of Indium-Herceptin.
* Blood samples are obtained every day of scanning to monitor the effects, if any, of the Indium-Herceptin and to see how fast the agent leaves the body.

Conditions

Interventions

DRUG

111Indium CHX-A

111Indium CHX-A will be administered intravenously over a 10-15 minute period using an intravenous catheter

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Peter L Choyke, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-01
Primary Completion
2014-08-20
Completion
2014-08-20
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 NCT01445054 on ClinicalTrials.gov