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
ClinicalTrials.gov Identifier:
First received: February 27, 2012
Last updated: December 18, 2015
Last verified: December 2015
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SUVavg in Each Colonic Segment [ Time Frame: Day 2 ] [ Designated as safety issue: No ]

Enrollment: 30
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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov 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
ClinicalTrials.gov Identifier: NCT01542541     History of Changes
Other Study ID Numbers: 2010-P-000101 
Study First Received: February 27, 2012
Results First Received: December 18, 2015
Last Updated: December 18, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Infective Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016