PET/CT Evaluation of Treatment Response in Breast Cancer
NCT ID: NCT01222416
Last Updated: 2017-07-02
Study Results
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View full resultsBasic Information
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TERMINATED
NA
50 participants
INTERVENTIONAL
2010-10-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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fluorodeoxyglucose PET/CT (FDG-PET/CT)
A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical Administration [18F]-FDG
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.
fluorodeoxythymidine PET/CT (FLT-PET/CT)
A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical: [18F]-FLT
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.
Interventions
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Radiopharmaceutical Administration [18F]-FDG
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.
Radiopharmaceutical: [18F]-FLT
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.
Eligibility Criteria
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Inclusion Criteria
* Subjects are being considered for preoperative chemotherapy
* Subjects must be ≥ 18 years old. Sensor Sub-Study Only
* Palpable subcutaneous or known disease with one surface \<1cm below surface of skin.
* A subset of patients who have a mass located on any surface of the breast that is accessible for Lucerno sensor placement will have additional testing.
Exclusion Criteria
* Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "PET Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential).
* Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study.
* Intraluminal lesions will be excluded from the sensor sub-study.
* Non biopsy proven malignancy will be excluded from this study.
* Palpable subcutaneous or known disease with one surface \>1cm below surface of skin will be excluded from the sensor sub-study.
* Draining or exposed malignant tumor will be excluded from the sensor sub-study.
18 Years
FEMALE
No
Sponsors
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Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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A Bapsi Chakravarthy, MD
Associate Professor; Radiation Oncologist
Principal Investigators
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A. Bapsi Chakravarthy, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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VICC BRE 09108
Identifier Type: -
Identifier Source: org_study_id
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