CClinicalTrials.gg
CompletedNCT01542541Updated Dec 13, 2017Results posted

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

An interventional study of Rifaximin in Intestinal FDG Uptake, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-13.

Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Intestinal FDG Uptake
03

In context

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients undergoing clinically-indicated PET-CT scan for non-GI lymphoma

Exclusion criteria

Exclusion Criteria:

  • Patients with known Inflammatory Bowel Disease
  • Patients with known colon cancer
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Rifaximin

    Drug: Rifaximin

  • No intervention
    Control

    Randomly-selected matched PET-CT scans performed on same day as intervention group.

Interventions

  • DrugRifaximin

    550mg BID for 2 days

    Also known as: Xifaxan

06

What researchers measure

Primary outcomes

  1. SUVmax of FDG in Each Colonic Segment

    Time frame: Day 2

Secondary outcomes

  1. SUVavg in Each Colonic Segment

    Time frame: Day 2

07

Results

Posted Jan 27, 2016

Participant flow

Participant flow — Overall Study
MilestoneRifaximinControl
Started3830
Completed3030
Not completed80

Outcome measures

PrimarySUVmax of FDG in Each Colonic Segment
Time frame:
Day 2
Reported as:
Mean · SUV
SUVmax of FDG in Each Colonic Segment
SUVRifaximinControl
SUVmax of FDG in Each Colonic Segment4.6 ± 2.34.3 ± 2.7
SecondarySUVavg in Each Colonic Segment
Time frame:
Day 2
Reported as:
Mean · SUV
SUVavg in Each Colonic Segment
SUVRifaximinControl
SUVavg in Each Colonic Segment1.6 ± 0.91.8 ± 0.9

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Rifaximin—0/30 (0%)0/30 (0%)
Control—0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)RifaximinControlTotal
Mean56 ± 1956 ± 1956 ± 19
Sex: Female, Male
Sex: Female, Male(Participants)RifaximinControlTotal
Female171532
Male211536
Region of Enrollment
Region of Enrollment(participants)RifaximinControlTotal
United States383068
08

Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01542541
Lead sponsor
Beth Israel Deaconess Medical Center
Collaborators
Bausch Health Americas, Inc.
Responsible party
Alan C. Moss (Assistant Professor of Medicine, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Mar 2, 2012
Start date
Jul 2011
Primary completion
Oct 2012
Completion
Oct 2012
Results posted
Jan 27, 2016
Last update
Dec 13, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion