Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00039286|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18||Phase 1|
- 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 (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||October 2001|
|Primary Completion Date :||February 2009|
|Study Completion Date :||February 2009|
Experimental: 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.
|Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18|
- Determine the sensitivity, specificity, and accuracy [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039286
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Elisa Rush Port, MD||Memorial Sloan Kettering Cancer Center|