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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583323
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : August 21, 2014
Information provided by:
Mayo Clinic

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

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Study Type : Interventional  (Clinical Trial)
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 : February 2003
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Reduction of bowel activity [ Time Frame: 1hour ]

Secondary Outcome Measures :
  1. Reduction of stomach activity [ Time Frame: 1 hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Responsible Party: Val J. Lowe, Mayo Clinic Identifier: NCT00583323    
Other Study ID Numbers: 2051-02
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Atropine sulfate-diphenoxylate hydrochloride drug combination
Gastrointestinal Agents