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
N/A
N/A
Female
Breast Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Determine the sensitivity, specificity, and accuracy
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Elisa Rush Port, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
01-134
NCT ID:
NCT00039286
Start Date:
October 2001
Completion Date:
February 2009
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
