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

November 15, 2017 updated by: Alan C. Moss, Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rifaximin
Drug: Rifaximin
550mg BID for 2 days
Other Names:
  • Xifaxan
No Intervention: Control
Randomly-selected matched PET-CT scans performed on same day as intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SUVmax of FDG in Each Colonic Segment
Time Frame: Day 2
Day 2

Secondary Outcome Measures

Outcome Measure
Time Frame
SUVavg in Each Colonic Segment
Time Frame: Day 2
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010P000101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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