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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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1 February 2021 |
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Main ID: |
NCT04125511 |
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Date of registration:
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28/08/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Characterizing IgG4-RD With 68Ga-FAPI PET/CT
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Scientific title:
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Characterizing IgG4-related Disease With 68Ga-FAPI PET/CT |
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Date of first enrolment:
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November 1, 2019 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04125511 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. 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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China
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Contacts
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Name:
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Li Huo, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Peking Union Medical College Hospital |
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Name:
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Li Huo, M.D. |
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Address:
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Telephone:
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86-10-69155537 |
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Email:
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huoli@pumch.cn |
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Affiliation:
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Name:
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Li Huo, MD |
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Address:
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Telephone:
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Email:
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Huoli@pumch.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- suspected or confirmed untreated IgG4-RD patients;
- 18F-FDG PET/CT within two weeks;
- signed written consent.
Exclusion Criteria:
- pregnancy;
- breastfeeding;
- known allergy against FAPI
- any medical condition that in the opinion of the investigator may significantly
interfere with study compliance.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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IgG4-related Disease
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Intervention(s)
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Drug: 68Ga-FAPI
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Primary Outcome(s)
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Metabolic parameters
[Time Frame: through study completion, an average of 1 year]
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Secondary Outcome(s)
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Disease burden assessement
[Time Frame: through study completion, an average of 1 year]
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adverse events
[Time Frame: through study completion, an average of 1 year]
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FAPI expression and SUV
[Time Frame: through study completion, an average of 1 year]
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Diagnostic value
[Time Frame: through study completion, an average of 1 year]
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Prediction value
[Time Frame: through study completion, an average of 1 year]
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Secondary ID(s)
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PekingUMCHFAPI
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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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