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| Sponsor: | American College of Radiology Imaging Network |
|---|---|
| Collaborator: |
Virginia Commonwealth University |
| Information provided by (Responsible Party): | American College of Radiology Imaging Network |
| ClinicalTrials.gov Identifier: | NCT00572728 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: 3'-Deoxy-3'-18F Fluorothymidine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | A Phase II Study of 3'-Deoxy-3'-18F Fluorothymidine (FLT) in Invasive Breast |
| Estimated Enrollment: | 36 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
3'-Deoxy-3'-18F Fluorothymidine
|
Drug: 3'-Deoxy-3'-18F Fluorothymidine
0.07 mCi/kg with a maximum of 5 mCi frequency: before chemotherapy, mid-treatment, and just prior to surgical resection of residual tumor
Other Names:
Drug: 3'-Deoxy-3'-18F Fluorothymidine
0.7 mCi/kg
Other Name: FLT
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Paul R. Jolles, M.D. | 804-828-7975 | prjolles@vcu.edu |
| Contact: Megan Quinn | 804-828-8196 | mmquinn@vcu.edu |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Principal Investigator: Paul R. Jolles, MD | |
| Study Chair: | Lale Kostakoglu, MD, MPH | ACRIN |
More Information
| Responsible Party: | American College of Radiology Imaging Network |
| ClinicalTrials.gov Identifier: | NCT00572728 History of Changes |
| Obsolete Identifiers: | NCT00566293 |
| Other Study ID Numbers: | MCC-8029, N01CM27165, ACRIN-6688 |
| Study First Received: | December 11, 2007 |
| Last Updated: | April 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
18F-FLT Fluorothymidine breast cancer PET imaging |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |