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

NCT00583323 | Completed Phase 3 DMC

• 1 other identifier: 2051-02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Reduction of bowel activity

  1hour

Secondary Outcomes (1)

• Reduction of stomach activity

  1 hour

Study Arms (2)

1

EXPERIMENTAL

Lomotil given

Drug: Lomotil

2

PLACEBO COMPARATOR

Normal Saline given

Other: Normal saline

Interventions

Lomotil DRUG

Orally 10ml of Lomotil

1

Normal saline OTHER

10 ml orally

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 18 years of age or older
• Subjects pre-scheduled for clinically-indicated PET scan

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

MeSH Terms

Conditions

Lymphoma

Interventions

atropine sulfate-diphenoxylate hydrochloride drug combination; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: February 1, 2003
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: August 21, 2014

Record last verified: 2014-08