PET Respiratory Gating to Detect Hepatic Metastasis in Patients With Colon Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Southwestern Regional Medical Center

ClinicalTrials.gov Identifier:

NCT01401309

First received: January 24, 2011

Last updated: December 10, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 24, 2011
Last Updated Date	December 10, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 10, 2012)	Detecting [ Time Frame: Jan 2011 - Nov 2011 ] [ Designated as safety issue: No ] To exam if there is an improved sensitivity in detecting hepatic lesions using respiratory gating and if there is improvement in confidence defining lesions as benign or malignant
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01401309 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	PET Respiratory Gating to Detect Hepatic Metastasis in Patients With Colon Cancer
Official Title ^ICMJE	Effects of Respiratory Gating on FDG/PET Detection of Hepatic Metastasis in Patients With Colon Cancer
Brief Summary	This study is to examine if there is improved sensitivity in detecting hepatic lesions using respiratory gating and if there is an improvement in confidence defining lesions as benign or malignant.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with colon cancer
Condition ^ICMJE	Colon Cancer
Intervention ^ICMJE	Not Provided
Study Group/Cohort (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	Active, not recruiting
Enrollment ^ICMJE	81
Estimated Completion Date	December 2013
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with colon cancer 18 years or older Signed Informed Consent Form Blood Glucose of 200 or less prior to scan Exclusion Criteria: Patients with known hepatic metastasis
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01401309
Other Study ID Numbers ^ICMJE	SRMC 10-07
Has Data Monitoring Committee	Yes
Responsible Party	Southwestern Regional Medical Center
Study Sponsor ^ICMJE	Southwestern Regional Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Southwestern Regional Medical Center
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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