Early Prediction of Pathologic Complete Response (pathCR) With Fluoro-L-Thymidine (FLT) Positron Emission Tomography (PET)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Esophageal Cancer |
Drug: Fluoro-L-Thymidine |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 100 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fluoro-L-Thymidine
Injection pre-CRT and post-CRT
|
Drug: Fluoro-L-Thymidine
4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-CRT and post-CRT prior to esophagectomy.
Other Name: FLT
|
Detailed Description:
The goal of this study is to obtain preliminary data and initial estimates of the FLT ability(FluoroLThymidine)-PET (Positron Emission Tomography) to identify pathCR (pathologic complete response) patients who have esophageal carinoma and undergo Chemo-RT prior to surgery. Despite improvements in surgical management, long-term survival rates in patients with esophageal cancer have not changed dramatically. Achievement in pathCR after pre-operative CRT (chemoradiotherapy) is associated with improved patient outcomes; however, there is no effective method to predict pathological response before surgery. Thus, a patient with pathCR, for whom esophagectomy may be unnecessary, still undergoes surgery and faces the prohibitive side effects of this surgical procedure. Additionally, CRT is associated with considerable morbidities and tool to predict and avoid ineffective therapy are lacking. Because deregulated proliferation is one of the hallmarks of cancer and its proliferation rate is associated with aggressive biologic behavior and response to therapy, imaging the proliferative state of cancer cells by noninvasive functional imaging is of great interest. Recently 18F-FLT (3'deoxy33'-18F-fluorothymidine) has been reported as a promising PET radiopharmaceutical for imaging cancer proliferation and has been validated in several in vitro & in vivo models. However, only a few studies addressed its role in depicting changes in cancer proliferation and assessing response to CRT, and none of these studies have focused on esophageal cancer. We propose to conduct a pilot study to learn the optimal FLT PET imaging timepoint during the early course of CRT that has the highest predictive value for pathCR in patients with esophageal cancer.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with histologically diagnosed adenocarcinoma or squamous cell carcinoma of the esophagus and localregional disease (stages II and III) will be eligible for participation in this study.
Exclusion Criteria:
Patients with abnormal liver or renal function or peripheral neuropathy, and women with pregnancy or breastfeeding will be excluded.
Contacts and Locations| Contact: Mei Wang | 212-305-9490 |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Principal Investigator: K.S. Clifford Chao, MD | |
| Principal Investigator: | K.S. Clifford Chao, MD | Columbia University |
More Information
No publications provided
| Responsible Party: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT01065818 History of Changes |
| Other Study ID Numbers: | AAAD5444, R21CA121551 |
| Study First Received: | February 8, 2010 |
| Last Updated: | October 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Columbia University:
|
Esophageal cancer FLT-PET Chemoradiotherapy |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
ClinicalTrials.gov processed this record on October 17, 2012
