Radiation Dose in Humans From Orally Administered Tc99m-Heparin
Completed · Early Phase 1
Conditions studied: Eosinophilic Esophagitis
In brief
This is a research study of a new agent used for evaluation of inflammation in the GI tract. This agent is investigational and thus is being studied to determine appropriate dosing and administration in both normal controls (i.e. people without gastrointestinal complaints) and patients with eosinophilic disease (i.e. those with an immune reaction and inflammation in their bodies with a certain cell called an eosinophil). The study will test whether the radiolabeled agent will bind to the inflammation of eosinophilic esophagitis patients because an animal model of eosinophilic esophagitis which shows the striking deposition of eosinophil granule proteins is not available.
Key facts
- Study ID
- NCT04069429
- Run by
- University of Utah
- People needed
- 8
- Starts
- 2016-07-01
- Expected to finish
- 2020-10-01
- Last updated by the study team
- 2021-05-03
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 10 patients with diagnosed EoE (greater than 20 eosinophils per HPF) on esophageal biopsy will be included as the diseased population
- 7 controls (subjects without GI symptoms and known GI disease)
You may not qualify if…
- bleeding diathesis or contraindication to esophageal biopsies
- severe sleep apnea
- incarceration
- pregnancy
- inability to lie flat for 2 hours
- history of bleeding disorder
- Use of steroids
- Breast feeding
- Allergy to heparin or history of severe reaction to heparin
- allergy to mucomyst or severe asthma
Where it is running
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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