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

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00583323

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 III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Atropine Lomotil Fluorodeoxyglucose F18 Diethylpropion Diethylpropion hydrochloride Diphenoxylate Diphenoxylate hydrochloride Atropine sulfate

U.S. FDA Resources

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
1: Experimental Lomotil given	Drug: Lomotil Orally 10ml of Lomotil
2: Placebo Comparator 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

No Contacts or Locations Provided

More Information

No publications provided

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

Additional relevant MeSH terms:

Atropine sulfate-diphenoxylate hydrochloride combination
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Diethylpropion
Physiological Effects of Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Pharmacologic Actions
Antidiarrheals
Diphenoxylate
Anti-Obesity Agents

Lymphatic Diseases
Neoplasms
Sensory System Agents
Therapeutic Uses
Appetite Depressants
Peripheral Nervous System Agents
Analgesics
Lymphoproliferative Disorders
Central Nervous System Agents
Lymphoma
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010