Official Title: “Diphenoxylate / Atropine to Decrease Bowel 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.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment

Study Primary Completion Date: September 2005

Intervention(s) in this Clinical Trial

• Drug: Lomotil
  • Orally 10ml of Lomotil
• Other: Normal saline
  • 10 ml orally

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Lomotil given
• Placebo Comparator: 2
  • Normal Saline given

Primary Measures

• Reduction of bowel activity
  • Time Frame: 1hour
    Safety Issue?: No

Secondary Measures

• Reduction of stomach activity
  • Time Frame: 1 hour
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mayo Clinic

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00583323

Study ID Number: 2051-02

ClinicalTrials.gov Identifier: NCT00583323

Health Authority: United States: Mayo Clinic