Early Prediction of Pathologic Complete Response (pathCR) With Fluoro-L-Thymidine (FLT) Positron Emission Tomography (PET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Columbia University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01065818
First received: February 8, 2010
Last updated: October 27, 2011
Last verified: October 2011
  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)

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065818

Contacts
Contact: Mei Wang 212-305-9490

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: K.S. Clifford Chao, MD         
Sponsors and Collaborators
Columbia University
Investigators
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 Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Telbivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014