Early Prediction of Pathologic Complete Response (pathCR) With Fluoro-L-Thymidine (FLT) Positron Emission Tomography (PET)
Recruitment status was: Recruiting
The goal of this research study is to learn if a new type of PET scan (18F-FLT) can help to better detect changes of tumor growth rate (or how active) in esophagus cancer. Researchers will study at what time during treatment the 18F-FLT PET scan should be given to get the best results.
A Positron Emission Tomography (PET) scan is a type of scan that uses a radioactive solution to locate cancer cells inside the body. Using the PET scan, doctors can locate solid tumors and collect information about how "active" the cancer cells are.
For this study, a new type of solution, [F-18] fluoro-L-thymidine (FLT), will be used. FLT can detect actively growing tumor, and researchers hope that FLT may be able to help provide information about how well esophagus cancer treatment is working. This information could be used to help predict if the cancer will respond to treatment.
All enrolled subjects will receive 4D-PET/ CT imaging at pre-chemoradiotherapy (CRT) and post-CRT prior to the esophagectomy. At each time of the 4D-PET/ CT procedure, the subject will receive an injection of FLT which is an investigational pharmaceutical labeled with radioactive fluorine. Each scan process might take 45 to 60 minutes. The 4DPET/ CT imaging at pre-CRT and at post-CRT will be compared and evaluated with the pathological assessment of the surgical specimens.
Participation in this pilot study will not change the patients normal chemotherapy, radiation treatment, and surgery recommended the patients physician as parts of their standard of care.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Early Prediction of Pathology Response of Chemoradiotherapy With Fluoro-L-Thymidine (FLT) Positron Emission Tomography (PET)|
- Determine optimal timepoint during CRT that FLT-PET imaging can predict response [ Time Frame: 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Injection pre-CRT and post-CRT
4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-CRT and post-CRT prior to esophagectomy.
Other Name: FLT
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065818
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||K.S. Clifford Chao, MD||Columbia University|