Back to resultsRadiation Dose in Humans From Orally Administered Tc99m-Heparin
Primary Purpose
Eosinophilic Esophagitis
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computerized Tomography scan
Single Photon Emission Computed Tomography scans
Technetium Tc 99M
Planar Images
Esophagogastroduodenoscopy
Sponsored by
About this trial
This is an interventional basic science trial for Eosinophilic Esophagitis
Eligibility Criteria
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
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy Controls
Eosinophilic Esophagitis Patients
Arm Description
7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
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
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04069429
Brief Title
Radiation Dose in Humans From Orally Administered Tc99m-Heparin
Official Title
Radiation Dose in Humans From Orally Administered Tc99m-Heparin
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
October 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
dose assessment of orally administration of Tc99m-Heparin in healthy control and Eosinophilic Esophagitis patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
Arm Title
Eosinophilic Esophagitis Patients
Arm Type
Experimental
Arm 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
Intervention Type
Radiation
Intervention Name(s)
Computerized Tomography scan
Other Intervention Name(s)
CT scan
Intervention Description
imaging scan from a person's eyes to their thighs
Intervention Type
Radiation
Intervention Name(s)
Single Photon Emission Computed Tomography scans
Other Intervention Name(s)
SPECT scans
Intervention Description
imaging scan taken during, and after, the administration of the radioactive agent
Intervention Type
Drug
Intervention Name(s)
Technetium Tc 99M
Other Intervention Name(s)
Radioactive Heparin
Intervention Description
subjects are administered radioactive heparin as part of study participation.
Intervention Type
Radiation
Intervention Name(s)
Planar Images
Intervention Description
2 dimensional imaging - whole body planar scans
Intervention Type
Procedure
Intervention Name(s)
Esophagogastroduodenoscopy
Intervention Description
esophagogastroduodenoscopy with tissue biopsies
Primary Outcome Measure Information:
Title
Biodistribution of Tc99m-heparin
Description
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.
Time Frame
over approximately 24-26 hours
Title
Calculation of organ doses
Description
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).
Time Frame
over approximately 24-26 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Gleich, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Radiation Dose in Humans From Orally Administered Tc99m-Heparin
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