Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: Lomotil (Drug); Normal saline (Other)
Phase: Phase 3
Status: Completed
Sponsored by: Mayo Clinic
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.
Clinical Details
Official title: Diphenoxylate / Atropine to Decrease Bowel Activity During F-18 FDG PET
Study design: Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Primary outcome: Reduction of bowel activity
Secondary outcome: Reduction of stomach activity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: February 2003
Ending date: September 2005
Last updated: December 20, 2007
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