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Completed

NCT Number: NCT04069429

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized Tomography scan

Radiation

imaging scan from a person's eyes to their thighs

Other names: CT scan

Single Photon Emission Computed Tomography scans

Radiation

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

Other names: SPECT scans

Technetium Tc 99M

Drug

subjects are administered radioactive heparin as part of study participation.

Other names: Radioactive Heparin

Planar Images

Radiation

2 dimensional imaging - whole body planar scans

Esophagogastroduodenoscopy

Procedure

esophagogastroduodenoscopy with tissue biopsies

Primary outcomes

  1. Biodistribution of Tc99m-heparin

    Time frame: 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.

  2. Calculation of organ doses

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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