Breast Cancer Clinical Trial

Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer

Summary

RATIONALE: Imaging procedures such as positron emission tomography (PET) may improve the ability to detect the extent of breast cancer.

PURPOSE: Diagnostic trial to study the effectiveness of PET to detect the extent of breast cancer in women who have primary or recurrent breast cancer.

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Full Description

OBJECTIVES:

Determine the sensitivity, specificity, and accuracy of fludeoxyglucose F 18 (FDG) positron emission tomography (PET) as compared to conventional imaging in determining the extent of disease in women with primary or recurrent breast cancer.
Determine how often clinical management and operative intervention plans for patients are altered based on these FDG-PET scan findings.
Determine whether FDG-PET results in more accurate detection of disease in these patients.

OUTLINE: Patients receive fludeoxyglucose F 18 IV. Approximately 1 hour later, patients undergo positron emission tomography imaging. Some patients may undergo a repeat scan in 4-6 months.

PROJECTED ACCRUAL: (50 with primary disease and 50 with recurrent disease) will be accrued for this study within 1-2 years.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer for which surgical intervention is planned

Large primary breast cancer (i.e., larger than 5 cm, T3) as determined by prior biopsy, physical exam, or mammogram OR
Locally advanced breast cancer (T4) OR
Clinical suspicion of axillary nodal disease (N1-2) (i.e., stage IIB-IIIA) OR
Locally or regionally recurrent disease
No locally recurrent disease that is non-invasive (i.e., ductal carcinoma in situ)
No locally advanced disease (e.g., inflammatory breast cancer) that will be treated with neoadjuvant chemotherapy without surgery

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age:

Not specified

Sex:

Female

Menopausal status:

Not specified

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No other malignancy except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix
No known active infection
No autoimmune disease or inflammatory disease (e.g., sarcoidosis or rheumatoid arthritis)
Able to fast for 6 hours and tolerate a FDG-PET scan for the duration of the test
Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

See Disease Characteristics

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

118

Study ID:

NCT00039286

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

118

Study ID:

NCT00039286

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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