PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer
NCT ID: NCT01712815
Last Updated: 2023-08-14
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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TERMINATED
NA
12 participants
INTERVENTIONAL
2013-11-22
2022-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (fluorine F 18-clevudine PET/CT)
Patients receive fluorine F18-clevudine IV over 1 minute and then undergo PET/CT scan at baseline. Patients with HER2+ breast cancer also undergo fluorine F 18-clevudine PET/CT scan 2-3 weeks after the first course of treatment and after completion of treatment.
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
questionnaire administration
Ancillary studies
fluorine F 18-clevudine
Undergo fluorine F 18-clevudine PET/CT scan
positron emission tomography/computed tomography
Undergo fluorine F18-clevudine PET/CT scan
Interventions
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laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
questionnaire administration
Ancillary studies
fluorine F 18-clevudine
Undergo fluorine F 18-clevudine PET/CT scan
positron emission tomography/computed tomography
Undergo fluorine F18-clevudine PET/CT scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have one or more breast tumors visualized by conventional PET/CT, CT or magnetic resonance imaging (MRI) prior to the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU
* Have been diagnosed with a HER2+ invasive cancer of the breast
* Scheduled to receive pre-operative therapy with trastuzumab plus chemotherapy as part of standard care
* Have one or more breast tumors visualized by conventional PET/CT, CT or MRI prior to the PET FMAU study; PET/CT should be within a week prior to 18-F FMAU
Exclusion Criteria
* Women of childbearing potential, unless they have had a negative urine human chorionic gonadotropin (HCG) within the previous 24 hours of the procedure
* Patients who have had surgery at the site of the suspected lesion within 1 month
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Peter Conti, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2012-02041
Identifier Type: REGISTRY
Identifier Source: secondary_id
1B-11-9
Identifier Type: -
Identifier Source: org_study_id
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