Overview

This trial is active, not recruiting.

Condition esophageal cancer
Treatment c11-choline
Phase phase 1
Sponsor Comprehensive Cancer Center of Wake Forest University
Start date March 2010
End date August 2013
Trial size 22 participants
Trial identifier NCT01051479, CCCWFU 60109

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
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

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.