Radiation Dose in Humans From Orally Administered Tc99m-Heparin

Utah System of Higher Education (USHE)

Status and phase: Completed; Early Phase 1

Conditions: Eosinophilic Esophagitis

Treatments: Radiation: Planar Images; Drug: Technetium Tc 99M; Procedure: Esophagogastroduodenoscopy; Radiation: Computerized Tomography scan; Radiation: Single Photon Emission Computed Tomography scans

Study type: Interventional

Funder types: Other

Identifiers

NCT04069429

IRB_00058734

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

8 participants in 2 patient groups

Healthy Controls

Experimental group

Description:

7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally

Treatment:

Radiation: Single Photon Emission Computed Tomography scans

Procedure: Esophagogastroduodenoscopy

Radiation: Computerized Tomography scan

Drug: Technetium Tc 99M

Radiation: Planar Images

Eosinophilic Esophagitis Patients

Experimental group

Description:

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

Treatment:

Radiation: Single Photon Emission Computed Tomography scans

Procedure: Esophagogastroduodenoscopy

Radiation: Computerized Tomography scan

Drug: Technetium Tc 99M

Radiation: Planar Images