Back to resultsA Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer
Primary Purpose
Esophageal Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
C11-Choline
Sponsored by
About this trial
This is an interventional diagnostic trial for Esophageal Cancer focused on measuring PET Positron emission tomography, CT X-ray computed tomography, Patients with Locally Advanced Esophageal Cancer
Eligibility 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.
Sites / Locations
- Wake Forest University Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C11-Choline
Arm Description
Outcomes
Primary Outcome Measures
To evaluate our ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer (pre- and post- chemotherapy).
Secondary Outcome Measures
Perform semi-quantitative analysis of tracer uptake using standard uptake values (SUV) and qualitative analysis using pure visual analysis.
Full Information
NCT ID
NCT01051479
First Posted
January 15, 2010
Last Updated
June 29, 2018
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01051479
Brief Title
A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer
Official Title
A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the investigators ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
PET Positron emission tomography, CT X-ray computed tomography, Patients with Locally Advanced Esophageal Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C11-Choline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
C11-Choline
Intervention Description
15 mCi 11C-choline will be administered intravenously as a bolus. The whole body emission scans will be acquired immediately following the tracer injection.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Perform semi-quantitative analysis of tracer uptake using standard uptake values (SUV) and qualitative analysis using pure visual analysis.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer
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