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Radiation Dose in Humans From Orally Administered Tc99m-Heparin

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Utah
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gerald Gleich, MD
Principal Investigator Affiliation University of Utah
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Arms & Interventions


Experimental: Healthy Controls

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

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Utah, Salt Lake City, Utah




University of Utah

Salt Lake City, Utah, 84132

Site Contact

Rachel Douglas



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