Radiation Dose in Humans From Orally Administered Tc99m-Heparin

Early Phase 1

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Radiation: Computerized Tomography scan; Radiation: Single Photon Emission Computed Tomography scans; Drug: Technetium Tc 99M; Radiation: Planar Images; Procedure: Esophagogastroduodenoscopy

• Registration Number: NCT04069429
• Lead Sponsor: University of Utah

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2019-07-27
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Primary Completion: 2020-09
• Study Completion: 2020-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eosinophilic Esophagitis Patients	Planar Images	10 patients with diagnosed EoE (greater than 15 eosinophils per HPF) on esophageal biopsy will be included as the diseased population, subjects will receive the radiopharmaceutical agent orally
Eosinophilic Esophagitis Patients	Esophagogastroduodenoscopy	10 patients with diagnosed EoE (greater than 15 eosinophils per HPF) on esophageal biopsy will be included as the diseased population, subjects will receive the radiopharmaceutical agent orally
Healthy Controls	Single Photon Emission Computed Tomography scans	7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
Healthy Controls	Computerized Tomography scan	7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
Healthy Controls	Planar Images	7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
Eosinophilic Esophagitis Patients	Computerized Tomography scan	10 patients with diagnosed EoE (greater than 15 eosinophils per HPF) on esophageal biopsy will be included as the diseased population, subjects will receive the radiopharmaceutical agent orally
Eosinophilic Esophagitis Patients	Single Photon Emission Computed Tomography scans	10 patients with diagnosed EoE (greater than 15 eosinophils per HPF) on esophageal biopsy will be included as the diseased population, subjects will receive the radiopharmaceutical agent orally
Healthy Controls	Esophagogastroduodenoscopy	7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
Healthy Controls	Technetium Tc 99M	7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
Eosinophilic Esophagitis Patients	Technetium Tc 99M	10 patients with diagnosed EoE (greater than 15 eosinophils per HPF) on esophageal biopsy will be included as the diseased population, subjects will receive the radiopharmaceutical agent orally

Primary Outcome Measures

Name	Time	Method
Biodistribution of Tc99m-heparin	over approximately 24-26 hours	Biodistribution of Tc99m-heparin to the esophagus and other organs, especially of the gastrointestinal tract as judged by planar scans and by single photon emission computed tomography scans.
Calculation of organ doses	over approximately 24-26 hours	Calculation of organ doses from the oral administration of Tc99m-heparin. The organ doses will be measured in miliSieverts using a computer program called OLINDA (Version 2).

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States