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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study To Assess The Utility Of 18F-Fluorodeoxyglucose Positron Emission Tomography (PET) In The Pre-Operative Evaluation Of Patients With Primary And Recurrent Breast Carcinoma

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: positron emission tomography
* Procedure: radionuclide imaging
* Radiation: fludeoxyglucose F 18


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positron Emission Tomography<br>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. | Procedure: positron emission tomography<br> <br> Procedure: radionuclide imaging<br> <br> Radiation: fludeoxyglucose F 18<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the sensitivity, specificity, and accuracy |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer