Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport (NIR-ICG MRL)
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|ClinicalTrials.gov Identifier: NCT04046146|
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Indocyanine Green Device: MultiSpectral Imaging System||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport|
|Actual Study Start Date :||December 15, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: NIR-ICG MRL
We may ask healthy subjects to return for up to four injection sessions for the study. The first injection session will consist of intradermal injection of ICG into the webspaces of the hand as done in our previous studies followed by NIR camera imaging. The second session will consist of intradermal gadolinium injection and intravenous (IV) iron contrast agent followed by MRI imaging approximately 1 week after the first session. The third session will occur at minimum eight weeks later and entail intra-articular ICG injection in order to evaluate drainage via the lymphatics. The MCP joints will be identified in the non-dominant hand and injected with ICG. Approximately one week later, the fourth session will compromise of intra-articular gadolinium injection and IV iron contrast to confirm lymphatic drainage. The MCP joints of the non-dominant hand will again be identified and injected with gadolinium.
Drug: Indocyanine Green
A trained physician will inject 0.1 ml of Indocyanine Green into the web spaces of the hands in both upper extremities. Subjects may have up to five study visits to confirm feasibility, safety, and reproducibility.
Device: MultiSpectral Imaging System
Once the Indocyanine Green is injected, the contrast is expected to fluoresce underneath the MultiSpectral Imaging System. Multispectral video and still images will be recorded at the study visits.
Other Name: MSImager
- 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 ]Vessel location and numbers will be identified using 2D still images from the NIR scanning sessions and with 2D MR images. These images will be superimposed upon each other in order to confirm concordance of lymphatic vessels. Number of lymphatic vessels in the hands will be manually counted.
- Lymphatic contraction rate measured via NIR ICG camera. Unit of measure: # contraction/minute [ Time Frame: 12 months ]Images collected from NIR scanning sessions will be analyzed to determine lymphatic contraction rate by identifying number of contractions per minute.
- ICG clearance measured from hand using NIR ICG images. Unit of measure: (% difference Visit 1 from Visit 2) [ Time Frame: 12 months ]2D still images collected from NIR scanning sessions will be analyzed to determine ICG clearance by comparing the % difference from visit 1 to visit 2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046146
|Contact: Dustina Holt, MPHfirstname.lastname@example.org|
|Contact: Amy Wielgosz, RNemail@example.com|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Amy Wielgosz, RN 585-275-1035 firstname.lastname@example.org|
|Principal Investigator: Homaira Rahimi, MD|
|Principal Investigator:||Homaira Rahimi, MD, MTR||University of Rochester|