- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00583323
Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET
August 20, 2014 updated by: Mayo Clinic
Diphenoxylate / Atropine to Decrease Bowel Activity During F-18 FDG PET
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Lomotil given
|
Orally 10ml of Lomotil
|
Placebo Comparator: 2
Normal Saline given
|
10 ml orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of bowel activity
Time Frame: 1hour
|
1hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of stomach activity
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Primary Completion (Actual)
September 1, 2005
Study Completion (Actual)
September 1, 2005
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 20, 2007
First Posted (Estimate)
December 31, 2007
Study Record Updates
Last Update Posted (Estimate)
August 21, 2014
Last Update Submitted That Met QC Criteria
August 20, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2051-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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