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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 May 2021 |
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Main ID: |
NCT04069429 |
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Date of registration:
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27/07/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Radiation Dose in Humans From Orally Administered Tc99m-Heparin
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Scientific title:
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Radiation Dose in Humans From Orally Administered Tc99m-Heparin |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04069429 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Gerald Gleich, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Utah |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Eosinophilic Esophagitis
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Intervention(s)
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Drug: Technetium Tc 99M
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Radiation: Computerized Tomography scan
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Procedure: Esophagogastroduodenoscopy
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Radiation: Planar Images
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Radiation: Single Photon Emission Computed Tomography scans
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Primary Outcome(s)
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Biodistribution of Tc99m-heparin
[Time Frame: over approximately 24-26 hours]
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Calculation of organ doses
[Time Frame: over approximately 24-26 hours]
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Secondary ID(s)
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IRB_00058734
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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