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Positron Emission Tomography in Patients With Breast Cancer
This study has been completed.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001385
  Purpose

This is a prospective study evaluating the role of Positron Emission Tomography (PET scan) in breast cancer. The radiopharmaceutical [18F] 2-deoxyglucose will be used as both an imaging modality and to evaluate tumor metabolism in patients with breast cancer. Patients with stage II, stage IIIA or IIIB, or stage IV breast cancer and evaluable disease in the breast and/or at metastatic sites will be studied. Patients will be injected intravenously with [18F]2-deoxyglucose and a PET scan conducted over 90 minutes. Examination of the role of PET scan in assessing the response of breast cancer to chemotherapy, especially in stage II and stage III patients, will be done. Up to three PET scans within one year may be performed. Findings by PET scan will be correlated both with those of concurrent imaging techniques (x-ray, CT scan, MRI, bone scan or mammogram), and with histologic, biochemical, and flow cytometric information on the tumor, and with findings in subsequent surgical specimens. Changes in tumor glucose metabolism with treatment will be assessed by PET imaging studies and by biochemical methods when possible.


Condition
Breast Neoplasms

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Mammography Nuclear Scans
U.S. FDA Resources
Study Type: Observational
Official Title: Positron Emission Tomography in Patients With Breast Cancer

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 75
Study Start Date: May 1994
Estimated Study Completion Date: April 2000
Detailed Description:

This is a prospective study evaluating the role of Positron Emission Tomography (PET scan) in breast cancer. The radiopharmaceutical [18F] 2-deoxyglucose will be used as both an imaging modality and to evaluate tumor metabolism in patients with breast cancer. Patients with stage II, stage IIIA or IIIB, or stage IV breast cancer and evaluable disease in the breast and/or at metastatic sites will be studied. Patients will be injected intravenously with [18F]2-deoxyglucose and a PET scan conducted over 90 minutes. Examination of the role of PET scan in assessing the response of breast cancer to chemotherapy, especially in stage II and stage III patients, will be done. Up to three PET scans within one year may be performed. Findings by PET scan will be correlated both with those of concurrent imaging techniques (x-ray, CT scan, MRI, bone scan or mammogram), and with histologic, biochemical, and flow cytometric information on the tumor, and with findings in subsequent surgical specimens. Changes in tumor glucose metabolism with treatment will be assessed by PET imaging studies and by biochemical methods when possible.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Histologically proven invasive carcinoma of the breast.

Patients with stage II, stage IIIA or IIIB, or stage IV breast cancer who have not received local therapy to the breast or axillary lymph nodes.

Evaluable tumor, either gross or microscopic, at locoregional and/or distant sites.

No current pregnancy.

No second invasive malignancy in addition to breast cancer.

No significant concurrent medical disorders (cardiac, renal, hepatic).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001385

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 940151, 94-C-0151
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001385  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cancer Diagnosis
Cancer Metabolism
FDG
FDG Breast Imaging
PET
Positron Emission Mammography
Radiopharmaceutical
Scintimammography

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009