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

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ClinicalTrials.gov Identifier: NCT00583323
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : August 21, 2014
Sponsor:
Information provided by:
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Lomotil Other: Normal saline Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Diphenoxylate / Atropine to Decrease Bowel Activity During F-18 FDG PET
Study Start Date : February 2003
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Lomotil given
Drug: Lomotil
Orally 10ml of Lomotil
Placebo Comparator: 2
Normal Saline given
Other: Normal saline
10 ml orally



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Responsible Party: Val J. Lowe, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00583323     History of Changes
Other Study ID Numbers: 2051-02
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Atropine
Diphenoxylate
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
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Antidiarrheals
Gastrointestinal Agents