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

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lomotil

Drug

Orally 10ml of Lomotil

Normal Saline

Other

10 ml orally

Primary outcomes

Reduction of bowel activity

Time frame: 1hour

Secondary outcomes

Reduction of stomach activity

Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Dec 31, 2007
Registry last updated: Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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