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Clinical Trials/NCT01051479
NCT01051479
Completed
Phase 1

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

Wake Forest University Health Sciences1 site in 1 country22 target enrollmentMarch 2010
InterventionsC11-Choline

Overview

Phase
Phase 1
Intervention
C11-Choline
Conditions
Esophageal Cancer
Sponsor
Wake Forest University Health Sciences
Enrollment
22
Locations
1
Primary Endpoint
To evaluate our ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer (pre- and post- chemotherapy).
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
August 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

C11-Choline

Intervention: C11-Choline

Outcomes

Primary Outcomes

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 Outcomes

  • Perform semi-quantitative analysis of tracer uptake using standard uptake values (SUV) and qualitative analysis using pure visual analysis.(2 years)

Study Sites (1)

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