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| Descriptive Information Fields | |||||||||
| Brief Title † | Safety and Efficacy Study of FLT Radiolabeled Imaging Agent With PET Scan in Invasive Breast Cancer | ||||||||
| Official Title † | A Phase II Study of 3'-Deoxy-3'-18F Fluorothymidine (FLT) in Invasive Breast | ||||||||
| Brief Summary | This trial will test the effectiveness of a new imaging agent, [F-18] FLT, in predicting the success of chemotherapy treatment. Imaging agents are drugs that are given before or during an imaging procedure to improve the quality of the images (like medical x-rays) that are obtained. When [F-18] FLT is used during positron emission tomography (PET) imaging, it may produce images that will tell in advance whether the tumor will respond to the treatment. |
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| Detailed Description | |||||||||
| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Screening, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | 18F]FLT uptake of the primary tumor in patients with locally advanced breast cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Vital signs, clinical laboratory tests, ECG [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] | ||||||||
| Condition † | Breast Cancer | ||||||||
| Intervention † | Drug: 3'-Deoxy-3'-18F Fluorothymidine | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 36 | ||||||||
| Start Date † | November 2007 | ||||||||
| Completion Date | November 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00572728 | ||||||||
| Organization ID | MCC-8029 | ||||||||
| Secondary IDs †† | N01CM27165 | ||||||||
| Study Sponsor † | Virginia Commonwealth University | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Virginia Commonwealth University | ||||||||
| Verification Date | June 2008 | ||||||||
| First Received Date † | December 11, 2007 | ||||||||
| Last Updated Date | June 3, 2008 | ||||||||