A Clinical Study to Limit Physiologic Intestinal FDG Upta... | NCT01542541

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

NCT01542541

Sponsor

Beth Israel Deaconess Medical Center

Status

Completed

Last Update Posted

Dec 13, 2017Actual

Enrollment

68Actual

Phase

Not Applicable

Conditions

Intestinal FDG Uptake

Interventions

Rifaximin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Feb 27, 2012

First Submission Date that Met QC Criteria

Feb 27, 2012

First Posted Date

Mar 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Dec 18, 2015

Results First Submitted that Met QC Criteria

Dec 18, 2015

Results First Posted Date

Jan 27, 2016Estimated

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2017

Last Update Posted Date

Dec 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alan C. Moss, Assistant Professor of Medicine, Beth Israel Deaconess Medical CenterPrincipal Investigator

Lead Sponsor

Beth Israel Deaconess Medical CenterOTHER

Collaborators

Name	Class
Bausch Health Americas, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rifaximin	Experimental		Drug: Rifaximin
Control	No Intervention	Randomly-selected matched PET-CT scans performed on same day as intervention group.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rifaximin	Drug	550mg BID for 2 days	Rifaximin	Xifaxan

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
SUVavg in Each Colonic Segment		Day 2

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02215	United States

Arm/Group Information

ID	Title	Description
FG000	Rifaximin	Rifaximin: 550mg BID for 2 days
FG001	Control	Randomly-selected matched PET-CT scans performed on same day as intervention group.

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Rifaximin	Rifaximin: 550mg BID for 2 days
BG001	Control	Randomly-selected matched PET-CT scans performed on same day as intervention group.

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

SUVmax of FDG in Each Colonic Segment

Posted

Mean

Standard Deviation

SUV

Day 2

ID	Title	Description
OG000	Rifaximin	Rifaximin: 550mg BID for 2 days
OG001	Control	Randomly-selected matched PET-CT scans performed on same day as intervention group.

Units	Counts
Participants

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rifaximin	Rifaximin: 550mg BID for 2 days

Serious Adverse Events

Not provided

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Dr Alan Moss	BIDMC	6176673197		amoss@bidmc.harvard.edu

Intervention Browse Module

MeSH Terms

ID	Term
D000078262	Rifaximin

Ancestor Terms

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided