Radiation Dose in Humans From Orally Administered Tc99m-Heparin

Study Overview
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Brief Summary
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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.

Official Title
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Radiation Dose in Humans From Orally Administered Tc99m-Heparin

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Radiation: Computerized Tomography scan
* Radiation: Single Photon Emission Computed Tomography scans
* Drug: Technetium Tc 99M
* Radiation: Planar Images
* Procedure: Esophagogastroduodenoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: dose assessment of orally administration of Tc99m-Heparin in healthy control and Eosinophilic Esophagitis patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Controls<br>7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally | Radiation: Computerized Tomography scan<br>* imaging scan from a person's eyes to their thighs<br>* Other names: CT scan;Radiation: Single Photon Emission Computed Tomography scans<br>* imaging scan taken during, and after, the administration of the radioactive agent<br>* Other names: SPECT scans;Drug: Technetium Tc 99M<br>* subjects are administered radioactive heparin as part of study participation.<br>* Other names: Radioactive Heparin;Radiation: Planar Images<br>* 2 dimensional imaging - whole body planar scans<br>Procedure: Esophagogastroduodenoscopy<br>* esophagogastroduodenoscopy with tissue biopsies<br>|
| Experimental: Eosinophilic Esophagitis Patients<br>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<br>* imaging scan from a person's eyes to their thighs<br>* Other names: CT scan;Radiation: Single Photon Emission Computed Tomography scans<br>* imaging scan taken during, and after, the administration of the radioactive agent<br>* Other names: SPECT scans;Drug: Technetium Tc 99M<br>* subjects are administered radioactive heparin as part of study participation.<br>* Other names: Radioactive Heparin;Radiation: Planar Images<br>* 2 dimensional imaging - whole body planar scans<br>Procedure: Esophagogastroduodenoscopy<br>* esophagogastroduodenoscopy with tissue biopsies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |