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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583323
• Other study ID #: 2051-02
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2007
• Last updated: August 20, 2014
• Start date: February 2003
• Est. completion date: September 2005

Study information

• Verified date: August 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Mayo Clinic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• Lomotil
Orally 10ml of Lomotil

Other:
• Normal saline
10 ml orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of bowel activity		1hour	No
Secondary	Reduction of stomach activity		1 hour	No