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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
  Purpose
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: None (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 Alan C. Moss, 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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542541


Locations
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: 2010P000101
First Submitted: February 27, 2012
First Posted: March 2, 2012
Results First Submitted: December 18, 2015
Results First Posted: January 27, 2016
Last Update Posted: October 11, 2017
Last Verified: September 2017

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