A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans
1 other identifier
interventional
68
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
January 27, 2016
CompletedDecember 13, 2017
November 1, 2017
1.3 years
February 27, 2012
December 18, 2015
November 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
SUVmax of FDG in Each Colonic Segment
Day 2
Secondary Outcomes (1)
SUVavg in Each Colonic Segment
Day 2
Study Arms (2)
Rifaximin
EXPERIMENTALControl
NO INTERVENTIONRandomly-selected matched PET-CT scans performed on same day as intervention group.
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing clinically-indicated PET-CT scan for non-GI lymphoma
You may not qualify if:
- Patients with known Inflammatory Bowel Disease
- Patients with known colon cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- Bausch Health Americas, Inc.collaborator
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Alan Moss
- Organization
- BIDMC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
February 27, 2012
First Posted
March 2, 2012
Study Start
July 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
December 13, 2017
Results First Posted
January 27, 2016
Record last verified: 2017-11