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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00583323
First received: December 20, 2007
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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
Lymphoma
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of stomach activity [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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

No publications provided

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

Additional relevant MeSH terms:
Diphenoxylate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antidiarrheals
Gastrointestinal Agents

ClinicalTrials.gov processed this record on October 19, 2014