NCT04069429

Radiation Dose in Humans From Orally Administered Tc99m-Heparin

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
RADIATION	Computerized Tomography scan	imaging scan from a person's eyes to their thighs
RADIATION	Single Photon Emission Computed Tomography scans	imaging scan taken during, and after, the administration of the radioactive agent
DRUG	Technetium Tc 99M	subjects are administered radioactive heparin as part of study participation.
RADIATION	Planar Images	2 dimensional imaging - whole body planar scans
PROCEDURE	Esophagogastroduodenoscopy	esophagogastroduodenoscopy with tissue biopsies

Timeline

• Start date: 2016-07-01
• Primary completion: 2020-09-01
• Completion: 2020-10-01
• First posted: 2019-08-28
• Last updated: 2021-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study