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

This study has been completed.
Information provided by:
Mayo Clinic Identifier:
First received: December 20, 2007
Last updated: August 20, 2014
Last verified: August 2014
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.

Condition Intervention Phase
Drug: Lomotil
Other: Normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Diphenoxylate / Atropine to Decrease Bowel Activity During F-18 FDG PET

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Reduction of bowel activity [ Time Frame: 1hour ]

Secondary Outcome Measures:
  • Reduction of stomach activity [ Time Frame: 1 hour ]

Enrollment: 60
Study Start Date: February 2003
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lomotil given
Drug: Lomotil
Orally 10ml of Lomotil
Placebo Comparator: 2
Normal Saline given
Other: Normal saline
10 ml orally


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Val J. Lowe, Mayo Clinic Identifier: NCT00583323     History of Changes
Other Study ID Numbers: 2051-02
Study First Received: December 20, 2007
Last Updated: August 20, 2014

Additional relevant MeSH terms:
Atropine sulfate-diphenoxylate hydrochloride drug combination
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Analgesics, Opioid
Central Nervous System Depressants
Sensory System Agents
Antidiarrheals processed this record on March 28, 2017