Rheumatoid ArthritisPhase 1NIR-ICG MRLNCT04046146
Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport
A Phase 1 study testing Indocyanine Green and MultiSpectral Imaging System in people with Rheumatoid Arthritis, run by University of Rochester at 1 site in United States.
Trial summary
Lymphatic transport will be examined using Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) and magnetic resonance lymphography (MRL) of the upper extremities. The purpose of the study is to establish if NIR-ICG is a valid clinical outcome for quantifying lymphatic vessel drainage. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Indocyanine Green and MultiSpectral Imaging System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2019to 15 Mar 2020
- Phase
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent.
- Subjects must be 18 years old or older.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Lymphatic transport will be examined using Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) and magnetic resonance lymphography (MRL) of the upper extremities. The purpose of the study is to establish if NIR-ICG is a valid clinical outcome for quantifying lymphatic vessel drainage.
Read the detailed description
Lymphedema from various etiologies (i.e. infection, cancer, surgery, and rheumatoid arthritis) remains a major health concern. Efforts to develop effective treatments for this condition have been limited by the absence of quantitative outcome measures for lymphatic function. Published articles have supported the fact that human lymphatic contractions can be readily visualized after intradermal administration of micrograms of Indocyanine Green using laser-induced fluorescence. We recently demonstrated the feasibility of NIR imaging to quantify lymphatic drainage in the hands, wrists and forearms of healthy volunteers following intradermal web space ICG injection into the hand . To establish this emerging technology as a valid clinical outcome measure, however, we must address two major questions that confound interpretation of the imaging results: 1) are the ICG filled vessels lymphatic vessels and/or small veins?; and 2) does NIR-ICG imaging following web space injection fully capture lymphatic flow from the metacarpophalangeal (MCP) joints that are most commonly involved in RA? To answer these questions, healthy patients will be recruited to have intradermal and intra-articular injections of ICG and gadolinium followed by an imaging sessions (NIR or magnetic resonance imaging) to measure lymphatic contraction rates and flow.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Indocyanine Green, MultiSpectral Imaging System
- Keywords
- Healthy Volunteers, Lymphatic Transport, Imaging, Indocyanine Green, Gadolinium, ICG, GAD, NIR-ICG, rhuematoid arthritis, NIR
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called ICG, IC-Green, 17478-701-02
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.
MultiSpectral Imaging SystemDevice
Also called MSImager
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.
| Study group | Role | What they receive |
|---|---|---|
| NIR-ICG MRL | Experimental | 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. Receives: Drug: Indocyanine Green; Device: MultiSpectral Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual lymphatic vessel counts via assessment of 2D images of NIR-ICG compared to MRI. Unit of measure: # lymphatic vessels/hand
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.
Measured: 12 months
Lymphatic contraction rate measured via NIR ICG camera. Unit of measure: # contraction/minute
Images collected from NIR scanning sessions will be analyzed to determine lymphatic contraction rate by identifying number of contractions per minute.
Measured: 12 months
ICG clearance measured from hand using NIR ICG images. Unit of measure: (% difference Visit 1 from Visit 2)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start15 Dec 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Homaira Rahimi, University of Rochester
- Investigators
- Homaira Rahimi, MD, MTR, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046146
- Sponsor's protocol ID
- STUDY3891
- Acronym
- NIR-ICG MRL
- Status last verified
- Sep 2020
- First submitted
- 23 Jul 2019
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information of any type may be shared with researchers at other institutions. Subjects will be made aware of this in the informed consent form.
Publications
Kenney HM, Dieudonne G, Yee S, Maki JH, Wood RW, Schwarz EM, Ritchlin CT, Rahimi H. Near-Infrared Imaging of Indocyanine Green Identifies Novel Routes of Lymphatic Drainage from Metacarpophalangeal Joints in Healthy Human Hands. Lymphat Res Biol. 2023 Aug;21(4):388-395. doi: 10.1089/lrb.2022.0026. Epub 2023 Feb 20.
PubMed 36809077
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport
- ClinicalTrials.gov ID
- NCT04046146
- Acronym / sponsor ID
- NIR-ICG MRL / STUDY3891
- Conditions
- Rheumatoid Arthritis
- Keywords
- Healthy Volunteers, Lymphatic Transport, Imaging, Indocyanine Green, Gadolinium, ICG, GAD, NIR-ICG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 6 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.
Lymphatic transport will be examined using Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) and magnetic resonance lymphography (MRL) of the upper extremities. The purpose of the study is to establish if NIR-ICG is a valid clinical outcome for quantifying lymphatic vessel drainage.
Detailed description
Lymphedema from various etiologies (i.e. infection, cancer, surgery, and rheumatoid arthritis) remains a major health concern. Efforts to develop effective treatments for this condition have been limited by the absence of quantitative outcome measures for lymphatic function. Published articles have supported the fact that human lymphatic contractions can be readily visualized after intradermal administration of micrograms of Indocyanine Green using laser-induced fluorescence. We recently demonstrated the feasibility of NIR imaging to quantify lymphatic drainage in the hands, wrists and forearms of healthy volunteers following intradermal web space ICG injection into the hand . To establish this emerging technology as a valid clinical outcome measure, however, we must address two major questions that confound interpretation of the imaging results: 1) are the ICG filled vessels lymphatic vessels and/or small veins?; and 2) does NIR-ICG imaging following web space injection fully capture lymphatic flow from the metacarpophalangeal (MCP) joints that are most commonly involved in RA? To answer these questions, healthy patients will be recruited to have intradermal and intra-articular injections of ICG and gadolinium followed by an imaging sessions (NIR or magnetic resonance imaging) to measure lymphatic contraction rates and flow.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIR-ICG MRL | Experimental | Drug: Indocyanine Green, Device: MultiSpectral Imaging SystemWe 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to provide written informed consent.
- Subjects must be 18 years old or older.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Indocyanine GreenAlso: ICG, IC-Green, 17478-701-02A 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. | Drug | NIR-ICG MRL |
| MultiSpectral Imaging SystemAlso: MSImagerOnce 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. | Device | NIR-ICG MRL |
Primary outcome
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.
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 4 Sep 2020.
- Derived from this study: PubMed 36809077Kenney HM, Dieudonne G, Yee S, Maki JH, Wood RW, Schwarz EM, Ritchlin CT, Rahimi H. Near-Infrared Imaging of Indocyanine Green Identifies Novel Routes of Lymphatic Drainage from Metacarpophalangeal Joints in Healthy Human Hands. Lymphat Res Biol. 2023 Aug;21(4):388-395. doi: 10.1089/lrb.2022.0026. Epub 2023 Feb 20.
- Individual participant dataSharing planned: Yes. Information of any type may be shared with researchers at other institutions. Subjects will be made aware of this in the informed consent form.
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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.
Homaira Rahimi, MD, MTR principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indocyanine Green and MultiSpectral Imaging System in people with Rheumatoid Arthritis, run by University of Rochester 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 5 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 4 Sep 2020. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04046146, which also lists 1 linked publication.
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 4 Sep 2020.