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NCT01051479 Clinical Trial

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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01051479
Other study ID # IRB00012072
Secondary ID CCCWFU 60109
Status Completed
Phase Phase 1
First received
Last updated
Start date March 2010
Est. completion date August 2013

Study information
Verified date June 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate our ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer (pre- and post- chemotherapy). 2 years
Secondary Perform semi-quantitative analysis of tracer uptake using standard uptake values (SUV) and qualitative analysis using pure visual analysis. 2 years
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