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A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542541
First Posted: March 2, 2012
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center
February 27, 2012
March 2, 2012
December 18, 2015
January 27, 2016
October 11, 2017
July 2011
October 2012   (Final data collection date for primary outcome measure)
SUVmax of FDG in Each Colonic Segment [ Time Frame: Day 2 ]
Same as current
Complete list of historical versions of study NCT01542541 on ClinicalTrials.gov Archive Site
SUVavg in Each Colonic Segment [ Time Frame: Day 2 ]
Same as current
Not Provided
Not Provided
 
A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans
A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans
Patients who undergo PET-CT scans to look for cancer are given an intravenous contrast (FDG) that is taken-up by active cells such as cancer cells. This contrast can then be seen in the body using the PET-CT scanner. However, cells in the colon also take up the FDG, and can produce "false positive" signals from the colon. Our hypothesis is that much of this signal comes from bacteria that are present in high concentrations in the colon. If this is the case, using an antibiotic to suppress the activity of bacteria may improve the ability of PET-CT to distinguish abnormal cells from normal cells in the colon.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Intestinal FDG Uptake
Drug: Rifaximin
550mg BID for 2 days
Other Name: Xifaxan
  • Experimental: Rifaximin
    Intervention: Drug: Rifaximin
  • No Intervention: Control
    Randomly-selected matched PET-CT scans performed on same day as intervention group.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
October 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing clinically-indicated PET-CT scan for non-GI lymphoma

Exclusion Criteria:

  • Patients with known Inflammatory Bowel Disease
  • Patients with known colon cancer
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01542541
2010P000101
No
Not Provided
Not Provided
Alan C. Moss, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Valeant Pharmaceuticals International, Inc.
Not Provided
Beth Israel Deaconess Medical Center
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP