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

Tracking Information
First Received Date ^ICMJE	January 15, 2010
Last Updated Date	January 31, 2013
Start Date ^ICMJE	March 2010
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 15, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01051479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 15, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer
Official Title ^ICMJE	A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Esophageal Cancer
Intervention ^ICMJE	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.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	20
Estimated Completion Date	January 2014
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01051479
Other Study ID Numbers ^ICMJE	CCCWFU 60109
Has Data Monitoring Committee	Yes
Responsible Party	Comprehensive Cancer Center of Wake Forest University
Study Sponsor ^ICMJE	Comprehensive Cancer Center of Wake Forest University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Comprehensive Cancer Center of Wake Forest University
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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