Radiation Dose in Humans From Orally Administered Tc99m-Heparin
NCT ID: NCT04069429
Last Updated: 2021-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
8 participants
INTERVENTIONAL
2016-07-31
2020-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter
NCT04668833
Radioembolization of Primary and Secondary Liver Malignancies and The Effect On The Immune System
NCT03889093
Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluation of Radiation-Induced Lung Injury in Subjects Undergoing Thoracic Irradiation
NCT03431129
Hyperpolarized Xenon-129 Magnetic Resonance Imaging in Lung Cancer Patients Receiving Radiation Therapy for Investigating Radiation-response and Toxicity
NCT06909201
Combination Targeted Radiotherapy in Neuroendocrine Tumors
NCT01099228
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy Controls
7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
Computerized Tomography scan
imaging scan from a person's eyes to their thighs
Single Photon Emission Computed Tomography scans
imaging scan taken during, and after, the administration of the radioactive agent
Technetium Tc 99M
subjects are administered radioactive heparin as part of study participation.
Planar Images
2 dimensional imaging - whole body planar scans
Esophagogastroduodenoscopy
esophagogastroduodenoscopy with tissue biopsies
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
Computerized Tomography scan
imaging scan from a person's eyes to their thighs
Single Photon Emission Computed Tomography scans
imaging scan taken during, and after, the administration of the radioactive agent
Technetium Tc 99M
subjects are administered radioactive heparin as part of study participation.
Planar Images
2 dimensional imaging - whole body planar scans
Esophagogastroduodenoscopy
esophagogastroduodenoscopy with tissue biopsies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Computerized Tomography scan
imaging scan from a person's eyes to their thighs
Single Photon Emission Computed Tomography scans
imaging scan taken during, and after, the administration of the radioactive agent
Technetium Tc 99M
subjects are administered radioactive heparin as part of study participation.
Planar Images
2 dimensional imaging - whole body planar scans
Esophagogastroduodenoscopy
esophagogastroduodenoscopy with tissue biopsies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 7 controls (subjects without GI symptoms and known GI disease)
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Utah
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gerald J. Gleich
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gerald Gleich, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Utah
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB_00058734
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.