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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Lomotil given

Group Type EXPERIMENTAL

Lomotil

Intervention Type DRUG

Orally 10ml of Lomotil

2

Normal Saline given

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type OTHER

10 ml orally

Interventions

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Lomotil

Orally 10ml of Lomotil

Intervention Type DRUG

Normal saline

10 ml orally

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes