Positron Emission Tomography in Patients With Breast Cancer

NCT ID: NCT00001385

Last Updated: 2008-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1994-05-31
• Study Completion Date: 2000-04-30

Brief 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.

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.

Conditions

Breast Neoplasms

Eligibility Criteria

Inclusion 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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Locations

National Cancer Institute (NCI)

Bethesda, Maryland, United States

Countries

United States

References

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. doi: 10.1148/radiology.179.3.2027989.

Reference Type: BACKGROUND

PMID: 2027989 (View on PubMed)

Di Chiro G, Brooks RA. PET-FDG of untreated and treated cerebral gliomas. J Nucl Med. 1988 Mar;29(3):421-3. No abstract available.

Reference Type: BACKGROUND

PMID: 3258029 (View on PubMed)

Other Identifiers

94-C-0151

Identifier Type: -

Identifier Source: secondary_id

940151

Identifier Type: -

Identifier Source: org_study_id