Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiation Dose in Humans From Orally Administered Tc99m-Heparin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069429
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Gerald J. Gleich, University of Utah

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.


Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Radiation: Computerized Tomography scan Radiation: Single Photon Emission Computed Tomography scans Drug: Technetium Tc 99M Radiation: Planar Images Procedure: Esophagogastroduodenoscopy Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: dose assessment of orally administration of Tc99m-Heparin in healthy control and Eosinophilic Esophagitis patients
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Radiation Dose in Humans From Orally Administered Tc99m-Heparin
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: Healthy Controls
7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
Radiation: Computerized Tomography scan
imaging scan from a person's eyes to their thighs
Other Name: CT scan

Radiation: Single Photon Emission Computed Tomography scans
imaging scan taken during, and after, the administration of the radioactive agent
Other Name: SPECT scans

Drug: Technetium Tc 99M
subjects are administered radioactive heparin as part of study participation.
Other Name: Radioactive Heparin

Radiation: Planar Images
2 dimensional imaging - whole body planar scans

Procedure: Esophagogastroduodenoscopy
esophagogastroduodenoscopy with tissue biopsies

Experimental: Eosinophilic Esophagitis Patients
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
imaging scan from a person's eyes to their thighs
Other Name: CT scan

Radiation: Single Photon Emission Computed Tomography scans
imaging scan taken during, and after, the administration of the radioactive agent
Other Name: SPECT scans

Drug: Technetium Tc 99M
subjects are administered radioactive heparin as part of study participation.
Other Name: Radioactive Heparin

Radiation: Planar Images
2 dimensional imaging - whole body planar scans

Procedure: Esophagogastroduodenoscopy
esophagogastroduodenoscopy with tissue biopsies




Primary Outcome Measures :
  1. Biodistribution of Tc99m-heparin [ Time Frame: over approximately 24-26 hours ]
    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.

  2. Calculation of organ doses [ Time Frame: over approximately 24-26 hours ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069429


Contacts
Layout table for location contacts
Contact: Rachel Douglas 801-213-0373 rachel.douglas@hsc.utah.edu

Locations
Layout table for location information
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Rachel Douglas    801-213-0373    rachel.douglas@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
Layout table for investigator information
Principal Investigator: Gerald Gleich, MD University of Utah
Layout table for additonal information
Responsible Party: Gerald J. Gleich, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT04069429    
Other Study ID Numbers: IRB_00058734
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action