Radiation Dose in Humans From Orally Administered Tc99m-Heparin

NCT04069429 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB_00058734
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Healthy Controls

EXPERIMENTAL

7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally

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

Eosinophilic Esophagitis Patients

EXPERIMENTAL

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; Radiation: Single Photon Emission Computed Tomography scans; Drug: Technetium Tc 99M; Radiation: Planar Images; Procedure: Esophagogastroduodenoscopy

Interventions

Computerized Tomography scan RADIATION

imaging scan from a person's eyes to their thighs

Also known as: CT scan

Eosinophilic Esophagitis Patients; Healthy Controls

Single Photon Emission Computed Tomography scans RADIATION

imaging scan taken during, and after, the administration of the radioactive agent

Also known as: SPECT scans

Eosinophilic Esophagitis Patients; Healthy Controls

Technetium Tc 99M DRUG

subjects are administered radioactive heparin as part of study participation.

Also known as: Radioactive Heparin

Eosinophilic Esophagitis Patients; Healthy Controls

Planar Images RADIATION

2 dimensional imaging - whole body planar scans

Eosinophilic Esophagitis Patients; Healthy Controls

Esophagogastroduodenoscopy PROCEDURE

esophagogastroduodenoscopy with tissue biopsies

Eosinophilic Esophagitis Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with diagnosed EoE (greater than 20 eosinophils per HPF) on esophageal biopsy will be included as the diseased population
• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Technetium; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Gerald Gleich, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: dose assessment of orally administration of Tc99m-Heparin in healthy control and Eosinophilic Esophagitis patients

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: August 28, 2019
• Study Start: July 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)