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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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12 December 2020 |
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Main ID: |
NCT04046146 |
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Date of registration:
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23/07/2019 |
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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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Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport
NIR-ICG MRL |
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Scientific title:
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Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport |
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Date of first enrolment:
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December 15, 2019 |
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Target sample size:
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2 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04046146 |
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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: Basic Science. Masking: None (Open Label).
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Phase:
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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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Homaira Rahimi, MD, MTR |
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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 Rochester |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Ability to provide written informed consent.
- Subjects must be 18 years old or older.
Exclusion Criteria:
- Active systemic disorders or inflammatory conditions (i.e., chronic infections with
hepatitis B, hepatitis C or HIV) that would confound the study results.
- Known sensitivity to iodine because of residual iodide in indocyanine green
- Known sensitivity to gadolinium
- Any history of kidney disease
- Pregnant women should not participate; pregnancy tests will not be performed.
Age minimum:
18 Years
Age maximum:
89 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Device: MultiSpectral Imaging System
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Drug: Indocyanine Green
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Primary Outcome(s)
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Manual lymphatic vessel counts via assessment of 2D images of NIR-ICG compared to MRI. Unit of measure: # lymphatic vessels/hand
[Time Frame: 12 months]
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ICG clearance measured from hand using NIR ICG images. Unit of measure: (% difference Visit 1 from Visit 2)
[Time Frame: 12 months]
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Lymphatic contraction rate measured via NIR ICG camera. Unit of measure: # contraction/minute
[Time Frame: 12 months]
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Secondary ID(s)
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STUDY3891
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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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