Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
NCT ID: NCT00039286
Last Updated: 2015-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
118 participants
INTERVENTIONAL
2001-10-31
2009-02-28
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Positron Emission Tomography
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.
positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
Interventions
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positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
Eligibility Criteria
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Inclusion Criteria
* 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
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Elisa Rush Port, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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MSKCC-01134
Identifier Type: -
Identifier Source: secondary_id
NCI-G02-2074
Identifier Type: -
Identifier Source: secondary_id
01-134
Identifier Type: -
Identifier Source: org_study_id