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

This study is currently recruiting participants.
Verified August 2012 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01542541
First received: February 27, 2012
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  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
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:

Drug Information available for: Rifaximin
U.S. FDA Resources

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 ]

Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: October 2012
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542541

Contacts
Contact: Alan C Moss, MD 617-667-3197 amoss@bidmc.harvard.edu
Contact: Anne Gifford, MPH 617-667-0558 agifford@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Anne Gifford, MPH     617-667-0558     agifford@bidmc.harvard.edu    
Principal Investigator: Alan C Moss, MD            
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Salix Pharmaceuticals
  More Information

No publications provided

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
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013