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

This study has been completed.
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center Identifier:
First received: February 27, 2012
Last updated: March 2, 2017
Last verified: March 2017
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.

Condition Intervention
Intestinal FDG Uptake
Drug: Rifaximin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans

Resource links provided by NLM:

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • SUVmax of FDG in Each Colonic Segment [ Time Frame: Day 2 ]

Secondary Outcome Measures:
  • SUVavg in Each Colonic Segment [ Time Frame: Day 2 ]

Enrollment: 68
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rifaximin Drug: Rifaximin
550mg BID for 2 days
Other Name: Xifaxan
No Intervention: Control
Randomly-selected matched PET-CT scans performed on same day as intervention group.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01542541

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Valeant Pharmaceuticals International, Inc.
  More Information

Responsible Party: Alan C. Moss, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center Identifier: NCT01542541     History of Changes
Other Study ID Numbers: 2010P000101
Study First Received: February 27, 2012
Results First Received: December 18, 2015
Last Updated: March 2, 2017

Additional relevant MeSH terms:
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 27, 2017