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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00583323

Enrollment

Registered

2007-12-31

Start date

2003-02-28

Completion date

2005-09-30

Last updated

2014-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

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.

Interventions

DRUGLomotil

Orally 10ml of Lomotil

OTHERNormal saline

10 ml orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Reduction of bowel activity	1hour

Secondary

Measure	Time frame
Reduction of stomach activity	1 hour

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026