Positron Emission Tomography in Patients With Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Positron Emission Tomography in Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001385
• Other study ID #: 940151
• Secondary ID: 94-C-0151
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: May 1994
• Est. completion date: April 2000

Study information

• Verified date: May 1999
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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).

Study Design

N/A

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Di Chiro G, Brooks RA. PET-FDG of untreated and treated cerebral gliomas. J Nucl Med. 1988 Mar;29(3):421-3. — View Citation

Wahl RL, Cody RL, Hutchins GD, Mudgett EE. Primary and metastatic breast carcinoma: initial clinical evaluation with PET with the radiolabeled glucose analogue 2-[F-18]-fluoro-2-deoxy-D-glucose. Radiology. 1991 Jun;179(3):765-70. — View Citation