Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00583323

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

2-[18F]-fluoro-2-deoxyD-glucose positron emission tomography (FDG PET) has proven to be a valuable clinical tool for the staging and surveillance of lymphoma.1-6 Occasionally, lymph nodes in the mesentery and retroperitoneum can be difficult to distinguish from normal bowel activity on PET scans despite three-plane and cine maximal image projection (MIP) imaging. This uncertainty limits the clinical usefulness of PET in some cases of lymphoma.7-8 In addition, bowel activity can also hinder interpretation of PET scans in other types of solid tumors including melanoma and colorectal cancer.6,9,10 Our goal is to determine how well diphenoxylate/atropine 5mg/0.05mg (Lomotil) decreases bowel activity and how this decrease impacts clinical decision-making, specifically for lymphoma staging and surveillance. This is a prospective, randomized, double-blinded study involving 60 patients undergoing PET scans for newly diagnosed or recurrent, untreated lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: Lomotil Other: Normal saline	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Diagnostic

Official Title:

Diphenoxylate / Atropine to Decrease Bowel Activity During F-18 FDG PET

Study Start Date :

Feb 1, 2003

Actual Primary Completion Date :

Sep 1, 2005

Actual Study Completion Date :

Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Lomotil given	Drug: Lomotil Orally 10ml of Lomotil
Placebo Comparator: 2 Normal Saline given	Other: Normal saline 10 ml orally

Arm

Intervention/Treatment

Experimental: 1

Lomotil given

Drug: Lomotil

Orally 10ml of Lomotil

Placebo Comparator: 2

Normal Saline given

Other: Normal saline

10 ml orally

Outcome Measures

Primary Outcome Measures

Reduction of bowel activity [1hour]

Secondary Outcome Measures

Reduction of stomach activity [1 hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

Males and females 18 years of age or older
Subjects pre-scheduled for clinically-indicated PET scan
Subjects with newly diagnosed or recurrent untreated disease (lymphoma) based on abdominal and/or pelvic adenopathy or masses on CT within 6 months of PET scan Exclusion Criteria
Allergy to Lomotil (Diphenoxylate hydrochloride, Atropine sulfate)
Subjects with one or more episodes of diarrhea within 24 hours prior to PET scan
Women who are breast-feeding
Subjects with a history of severe liver disease, jaundice, dehydration, or narrow-angle glaucoma

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mayo Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00583323

Other Study ID Numbers:

2051-02

First Posted:

Dec 31, 2007

Last Update Posted:

Aug 21, 2014

Last Verified:

Aug 1, 2014

Additional relevant MeSH terms:

Atropine sulfate-diphenoxylate hydrochloride drug combination

Study Results

No Results Posted as of Aug 21, 2014