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

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Atropine; Atropine sulfate-diphenoxylate hydrochloride drug combination; Diphenoxylate

Criteria

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