Clinical trial · Interventional
Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET
Diphenoxylate / Atropine to Decrease Bowel Activity During F-18 FDG PET
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lomotil | Drug | — | UNRESOLVED |
| Normal saline | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Lomotil given
- interventionNames
- Drug: Lomotil
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Normal Saline given
- interventionNames
- Other: Normal saline
Primary outcomes (1)
- measure
- Reduction of bowel activity
- timeFrame
- 1hour
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available