Radiation Dose in Humans From Orally Administered Tc99m-Heparin

Eosinophilic Esophagitis Clinical Trial

Official title:

Radiation Dose in Humans From Orally Administered Tc99m-Heparin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069429
• Other study ID #: IRB_00058734
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2016
• Est. completion date: October 2020

Study information

• Verified date: April 2021
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Radiation:
• Computerized Tomography scan
imaging scan from a person's eyes to their thighs
• 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

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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