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Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer

2014-08-27 03:14:58 | BioPortfolio

Summary

RATIONALE: Diagnostic procedures, such as 64 Cu-DOTA-trastuzumab-labeled positron emission tomography, may help doctors to plan a better treatment.

PURPOSE: This clinical trial is studying 64 Cu-DOTA-trastuzumab-labeled positron emission tomography in women with HER2-positive breast cancer.

Description

OBJECTIVES:

I. Determine the dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET without increasing the radiation dose to the heart in women with metastatic HER2 positive breast cancer.

II. Determine whether tumor uptake on 64Cu-DOTA-trastuzumab PET correlates with tumor expression of HER2 in women with metastatic disease.

III. Perform an exploratory analysis of the relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway.

OUTLINE:

Patients undergo a positron emission tomography scan 24 - 48 hours after injection of 64 Cu-DOTA-trastuzumab.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Breast Cancer

Intervention

positron emission tomography, copper Cu 64-DOTA-trastuzumab

Location

City of Hope
Duarte
California
United States
91010

Status

Not yet recruiting

Source

City of Hope Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:58-0400

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Medical and Biotech [MESH] Definitions

An imaging technique using compounds labelled with short-lived positron-emitting radionuclides (such as carbon-11, nitrogen-13, oxygen-15 and fluorine-18) to measure cell metabolism. It has been useful in study of soft tissues such as CANCER; CARDIOVASCULAR SYSTEM; and brain. SINGLE-PHOTON EMISSION-COMPUTED TOMOGRAPHY is closely related to positron emission tomography, but uses isotopes with longer half-lives and resolution is lower.

An imaging technique that combines a POSITRON-EMISSION TOMOGRAPHY (PET) scanner and a CT X RAY scanner. This establishes a precise anatomic localization in the same session.

A method of computed tomography that uses radionuclides which emit a single photon of a given energy. The camera is rotated 180 or 360 degrees around the patient to capture images at multiple positions along the arc. The computer is then used to reconstruct the transaxial, sagittal, and coronal images from the 3-dimensional distribution of radionuclides in the organ. The advantages of SPECT are that it can be used to observe biochemical and physiological processes as well as size and volume of the organ. The disadvantage is that, unlike positron-emission tomography where the positron-electron annihilation results in the emission of 2 photons at 180 degrees from each other, SPECT requires physical collimation to line up the photons, which results in the loss of many available photons and hence degrades the image.

An imaging technique using a device which combines TOMOGRAPHY, EMISSION-COMPUTED, SINGLE-PHOTON and TOMOGRAPHY, X-RAY COMPUTED in the same session.

A humanized monoclonal antibody against the ERBB-2 RECEPTOR (HER2). As an ANTINEOPLASTIC AGENT, it is used to treat BREAST CANCER where HER2 is overexpressed.

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