Eosinophilic EsophagitisEarly Phase 1NCT04069429
Radiation Dose in Humans From Orally Administered Tc99m-Heparin
A Early Phase 1 study testing Computerized Tomography scan, Single Photon Emission Computed Tomography scans and Technetium Tc 99M in people with Eosinophilic Esophagitis, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Computerized Tomography scan, Single Photon Emission Computed Tomography scans and Technetium Tc 99M
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Oct 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- bleeding diathesis or contraindication to esophageal biopsies
- severe sleep apnea
- incarceration
- pregnancy
- inability to lie flat for 2 hours
- history of bleeding disorder
Show all 10Show fewer
- Use of steroids
- Breast feeding
- Allergy to heparin or history of severe reaction to heparin
- allergy to mucomyst or severe asthma
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Computerized Tomography scan, Single Photon Emission Computed Tomography scans, Technetium Tc 99M, Planar Images, Esophagogastroduodenoscopy
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Tomography scanRadiation
Also called CT scan
imaging scan from a person's eyes to their thighs
Single Photon Emission Computed Tomography scansRadiation
Also called SPECT scans
imaging scan taken during, and after, the administration of the radioactive agent
Technetium Tc 99MDrug
Also called Radioactive Heparin
subjects are administered radioactive heparin as part of study participation.
Planar ImagesRadiation
2 dimensional imaging - whole body planar scans
EsophagogastroduodenoscopyProcedure or surgery
esophagogastroduodenoscopy with tissue biopsies
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | 7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally Receives: Radiation: Computerized Tomography scan; Radiation: Single Photon Emission Computed Tomography scans; Drug: Technetium Tc 99M; Radiation: Planar Images; Procedure: Esophagogastroduodenoscopy |
| Eosinophilic Esophagitis Patients | Experimental | 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 Receives: Radiation: Computerized Tomography scan; Radiation: Single Photon Emission Computed Tomography scans; Drug: Technetium Tc 99M; Radiation: Planar Images; Procedure: Esophagogastroduodenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: over approximately 24-26 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startJul 2016
- Primary completionSep 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- dose assessment of orally administration of Tc99m-Heparin in healthy control and Eosinophilic Esophagitis patients
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald J. Gleich, University of Utah
- Investigators
- Gerald Gleich, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069429
- Sponsor's protocol ID
- IRB_00058734
- Status last verified
- Apr 2021
- First submitted
- 27 Jul 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Dose in Humans From Orally Administered Tc99m-Heparin
- ClinicalTrials.gov ID
- NCT04069429
- Acronym / sponsor ID
- IRB_00058734
- Conditions
- Eosinophilic Esophagitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- dose assessment of orally administration of Tc99m-Heparin in healthy control and Eosinophilic Esophagitis patients
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Radiation: Computerized Tomography scan, Radiation: Single Photon Emission Computed Tomography scans, Drug: Technetium Tc 99M, Radiation: Planar Images, Procedure: Esophagogastroduodenoscopy7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally |
| Eosinophilic Esophagitis Patients | Experimental | Radiation: Computerized Tomography scan, Radiation: Single Photon Emission Computed Tomography scans, Drug: Technetium Tc 99M, Radiation: Planar Images, Procedure: Esophagogastroduodenoscopy10 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (10 listed)
- bleeding diathesis or contraindication to esophageal biopsies
- severe sleep apnea
- incarceration
- pregnancy
- inability to lie flat for 2 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Tomography scanAlso: CT scanimaging scan from a person's eyes to their thighs | Radiation | Eosinophilic Esophagitis Patients, Healthy Controls |
| Single Photon Emission Computed Tomography scansAlso: SPECT scansimaging scan taken during, and after, the administration of the radioactive agent | Radiation | Eosinophilic Esophagitis Patients, Healthy Controls |
| Technetium Tc 99MAlso: Radioactive Heparinsubjects are administered radioactive heparin as part of study participation. | Drug | Eosinophilic Esophagitis Patients, Healthy Controls |
| Planar Images2 dimensional imaging - whole body planar scans | Radiation | Eosinophilic Esophagitis Patients, Healthy Controls |
| Esophagogastroduodenoscopyesophagogastroduodenoscopy with tissue biopsies | Procedure or surgery | Eosinophilic Esophagitis Patients, Healthy Controls |
Primary outcome
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Gleich, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Computerized Tomography scan, Single Photon Emission Computed Tomography scans and Technetium Tc 99M in people with Eosinophilic Esophagitis, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of Tc99m-heparin (time frame: over approximately 24-26 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.