Radiation Dose in Humans From Orally Administered Tc99m-Heparin

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Healthy Controls; 7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally	Radiation: Computerized Tomography scan; imaging scan from a person's eyes to their thighs; Other Names: CT scan; Radiation: Single Photon Emission Computed Tomography scans; imaging scan taken during, and after, the administration of the radioactive agent; Other Names: SPECT scans; Drug: Technetium Tc 99M; subjects are administered radioactive heparin as part of study participation.; Other Names: Radioactive Heparin; Radiation: Planar Images; 2 dimensional imaging - whole body planar scans; Procedure: Esophagogastroduodenoscopy; esophagogastroduodenoscopy with tissue biopsies
EXPERIMENTAL: Eosinophilic Esophagitis Patients; 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	Radiation: Computerized Tomography scan; imaging scan from a person's eyes to their thighs; Other Names: CT scan; Radiation: Single Photon Emission Computed Tomography scans; imaging scan taken during, and after, the administration of the radioactive agent; Other Names: SPECT scans; Drug: Technetium Tc 99M; subjects are administered radioactive heparin as part of study participation.; Other Names: Radioactive Heparin; Radiation: Planar Images; 2 dimensional imaging - whole body planar scans; Procedure: Esophagogastroduodenoscopy; esophagogastroduodenoscopy with tissue biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biodistribution of Tc99m-heparin	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.	over approximately 24-26 hours
Calculation of organ doses	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).	over approximately 24-26 hours

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Gerald Gleich, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: July 27, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: IRB_00058734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No