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A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer

This study is currently recruiting participants.
Verified January 2013 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01051479
First received: January 15, 2010
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the investigators ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
 Drug: C11-Choline
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • To evaluate our ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer (pre- and post- chemotherapy). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perform semi-quantitative analysis of tracer uptake using standard uptake values (SUV) and qualitative analysis using pure visual analysis. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: C11-Choline
    15 mCi 11C-choline will be administered intravenously as a bolus. The whole body emission scans will be acquired immediately following the tracer injection.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed or recurrent patients with locally advanced esophageal cancer with either squamous or adenocarcinoma histology.
  • Ability to tolerate PET imaging
  • Prior malignancy is allowed, but the expectation of survival must be that beyond that expected for patients with locally advanced esophageal cancer.

Exclusion Criteria:

  • Pregnant or lactating females are not eligible for this pilot study.
  • Patients having received chemotherapy in the 3 months prior to registration for any reason
  • Patients with metastatic disease requiring chemoradiation for palliation are not allowed.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051479

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Margaret Crowley-Van Damme, LPN     336-713-6627     mcrowley@wfubmc.edu    
Principal Investigator: Arthur W. Blackstock, BS, MD            
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01051479     History of Changes
Other Study ID Numbers: CCCWFU 60109
Study First Received: January 15, 2010
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
PET Positron emission tomography
CT X-ray computed tomography
Patients with Locally Advanced Esophageal Cancer

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
Choline
 Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013