Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET
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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 |
- Reduction of bowel activity [ Time Frame: 1hour ] [ Designated as safety issue: No ]
- 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 |
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 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: | December 20, 2007 |
| Health Authority: | United States: Mayo Clinic |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Atropine Diphenoxylate Atropine sulfate-diphenoxylate hydrochloride combination Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents |
Cardiovascular 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 |
ClinicalTrials.gov processed this record on May 23, 2013