Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET
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About
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.
Enrollment
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Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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