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Radiation Dose in Humans From Orally Administered Tc99m-Heparin

NCT04069429 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-05-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Gerald Gleich, MD · University of Utah

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2020-09-30
Completion
2020-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04069429 on ClinicalTrials.gov