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

Memorial Sloan Kettering Cancer Center118 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

118

Conditions

Breast Cancer

Interventions

positron emission tomographyPROCEDURE

radionuclide imagingPROCEDURE

fludeoxyglucose F 18RADIATION

Eligibility

Sex: FEMALEMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Determine the sensitivity, specificity, and accuracy

Time frame: 2 years

Data from ClinicalTrials.gov

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