CompletedEarly Phase 1

Radiation Dose in Humans From Orally Administered Tc99m-Heparin

United States8 participantsStarted 2016-07

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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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

What they're measuring

Biodistribution of Tc99m-heparin

Timeframe: over approximately 24-26 hours

Calculation of organ doses

Timeframe: over approximately 24-26 hours

Trial details

NCT IDNCT04069429

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09

View on ClinicalTrials.gov More Eosinophilic Esophagitis trials