Indocyanine Green Imaging for Rotator Cuff Surgery

Overseen By Michael Moore

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NYU Langone Health

Disqualifiers: Iodide allergy, Recent iodide study, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve outcomes for individuals undergoing rotator cuff surgery, a common procedure for shoulder injuries. Researchers are testing a dye called Indocyanine Green (ICG) to enhance visibility of blood flow during surgery, which might help predict and prevent future tears. Participants will receive one of three different doses of ICG during their surgery to determine the optimal amount. Ideal candidates for this trial have a rotator cuff tear and plan to have it repaired through arthroscopic surgery. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Indocyanine Green (ICG) has been safely used in medical tests for over 30 years, aiding doctors in visualizing blood vessels more clearly during surgery. Some studies have applied ICG in procedures like rotator cuff repair to assess blood flow, with patients generally tolerating it well. However, reports have noted some mild side effects, such as itching or rash. As this trial is in its early phase, it aims to determine a safe dose of ICG for this specific use. The different doses being tested (7.5 mg, 12.5 mg, and 25 mg) are designed to provide clear imaging while minimizing side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Indocyanine Green (ICG) in rotator cuff surgery because it enhances surgical precision. Unlike traditional imaging methods, ICG binds to proteins in the blood, allowing surgeons to visualize blood vessels more clearly during the procedure. This improved visualization can potentially lead to better surgical outcomes and faster recovery for patients. By offering doses of 7.5 mg, 12.5 mg, and 25 mg, the trial aims to determine the optimal amount for the best surgical clarity, making it a promising advancement in surgical techniques.

What evidence suggests that Indocyanine Green is effective for visualizing rotator cuff vascularity?

Research shows that using Indocyanine Green (ICG) can improve outcomes in rotator cuff surgery. In this trial, participants will receive different doses of ICG (7.5 mg, 12.5 mg, or 25 mg) during surgery. Studies have found that patients who underwent surgery with ICG guidance experienced less pain six months later compared to those without ICG. ICG enhances the surgeon's ability to see blood vessels during the procedure, potentially improving rotator cuff repair. This visibility allows the surgeon to identify areas with good blood flow, crucial for healing. ICG has been safely used in other surgeries to enhance blood vessel visibility, suggesting its potential benefits in rotator cuff surgeries as well. ^{1 2 3 6 7}

Who Is on the Research Team?

Kirk Campbell, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults between 18 and 79 years old who are scheduled for arthroscopic repair of full or partial thickness rotator cuff tears. It's not suitable for pregnant individuals, those with recent iodide-based radiology studies, or anyone allergic to iodides.

Inclusion Criteria

I have a torn rotator cuff and will have surgery to fix it.

Exclusion Criteria

Patient has a documented allergy to iodides

Patients who have had iodide based radiology studies within the last seven (7) days prior to surgery

Patient is pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three doses of Indocyanine Green (ICG) intravenously during arthroscopic surgery to evaluate rotator cuff vascularity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, with assessments of rotator cuff vascularity using AIM arthroscopy videos

up to 6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Indocyanine Green

Trial Overview The study tests the optimal dosing of Indocyanine Green (ICG), a dye used in surgery to visualize blood vessels in the rotator cuff during arthroscopy, aiming to predict the success of surgical repairs.

How Is the Trial Designed?

Group I: Group 3: ICG 25 mg Experimental Treatment 1 Intervention

Subjects in this group are randomized to receive 25 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.

Group II: Group 2:ICG 12.5 mg Experimental Treatment 1 Intervention

Subjects in this group are randomized to receive 12.5 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.

Group III: Group 1:ICG 7.5 mg Experimental Treatment 1 Intervention

Subjects in this group are randomized to receive 7.5 mg dose of Indocyanine Green (ICG) intravenously during the clinical surgery. ICG is a substance that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision.

Indocyanine Green is already approved in United States, European Union, China, Japan for the following indications:

Approved in United States as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping

Approved in European Union as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping

Approved in China as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping, liver function testing

Approved in Japan as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping, liver function testing

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Indocyanine green (ICG) is a useful fluorescent dye in bariatric surgery that can help assess tissue perfusion and perform leak testing, potentially leading to intraoperative decision changes in 3.8% of cases.

The study highlights the need for further research to confirm the routine use of ICG in both standard and complex bariatric surgical procedures, indicating its promise in reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green in Bariatric Surgery: a Systematic Review. Hsu, A., Mu, SZ., James, A., et al.[2023]

Indocyanine green (ICG) is a fluorescent dye used in various surgical applications, including identifying sentinel lymph nodes and assessing skin perfusion during breast surgeries, highlighting its role in improving surgical outcomes.

ICG's ability to emit fluorescence when illuminated by near-infrared light allows for precise mapping of lymphatic networks and guidance in excising nonpalpable breast cancer, demonstrating its efficacy in oncological and reconstructive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of indocyanine green angiography in oncological and reconstructive breast surgery]. Struk, S., Honart, JF., Qassemyar, Q., et al.[2018]

A case study reported retinal toxicity from indocyanine green (ICG) after cataract surgery, highlighting a potential risk associated with its use in ocular procedures.

The patient showed significant recovery over six months, with improvements in visual acuity, normalization of electroretinography responses, and disappearance of visual field defects, indicating that ICG toxicity may be reversible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine green toxicity of the retina after cataract surgery: a case report. Ksiazek, S., Grover, S., Mojica, G., et al.[2014]

Indocyanine Green (ICG) is a fluorescent dye that helps surgeons visualize important anatomical structures and blood flow during various surgical procedures, enhancing the identification of tumors and lymphatic mapping.

While the initial evidence for ICG's effectiveness in surgery is promising, more standardized protocols and larger randomized studies are needed to confirm its benefits across general surgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine green (ICG) fluorescence guide for the use and indications in general surgery: recommendations based on the descriptive review of the literature and the analysis of experience. Morales-Conde, S., Licardie, E., Alarcón, I., et al.[2022]

In a study of 23 patients undergoing soft-tissue sarcoma resection, ICG angiography demonstrated a high specificity (100%) and positive predictive value (100%) for predicting postoperative wound complications, particularly in the lower extremity.

The sensitivity of ICG angiography was lower at 50%, indicating that while it is very accurate when it predicts complications, it may miss some cases, especially in areas other than the lower extremity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Indocyanine Green Fluorescence Angiography Is Sensitive for Predicting Postoperative Wound Complications in Soft-Tissue Sarcoma Surgery. Wilke, BK., Schultz, DS., Huayllani, MT., et al.[2021]

Indocyanine green (ICG) is a vital dye used in vitreoretinal surgery to improve visualization of delicate tissues, but its safety profile is limited, with reports of patients developing permanent central scotomas after surgery.

The use of ICG can enhance surgical techniques, but it does not guarantee improved visual outcomes, highlighting the need for careful application and consideration of safety issues during its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should Indocyanine green should be used to facilitate removal of the internal limiting membrane in macular hole surgery. Thompson, JT., Haritoglu, C., Kampik, A., et al.[2015]

Indocyanine green (ICG) fluorescence angiography effectively visualizes blood flow in the rotator cuff during surgery, demonstrating its potential as a real-time evaluation tool for soft tissue blood flow in orthopedic procedures.

In a study of 26 patients, those with adhesive capsulitis showed significantly earlier enhancement of blood flow and a smaller hypovascular area ratio compared to other groups, indicating that ICG can help assess vascular conditions of the rotator cuff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative evaluation of blood flow for soft tissues in orthopaedic surgery using indocyanine green fluorescence angiography: A pilot study. Doi, N., Izaki, T., Miyake, S., et al.[2022]

A 76-year-old woman experienced severe hemodynamic instability during coronary artery bypass surgery after receiving indocyanine green (ICG) to check graft patency, highlighting potential adverse effects of ICG.

The case emphasizes the need for careful monitoring of blood pressure and heart rate during ICG administration, as well as the importance of having emergency measures ready to address any severe reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe hemodynamic instability after indocyanine green injection during off-pump coronary artery bypass grafting: A case report. Zhai, Q., Wang, Y., Tian, A.[2022]

In a study involving 1226 patients and 1923 ICG videoangiography tests, the safety of intravenous indocyanine green (ICG) was confirmed, with only 0.15% experiencing mild adverse reactions and 0.2% moderate reactions.

The study found one severe adverse reaction (0.05%) but no fatalities, highlighting the high level of safety associated with ICG in ophthalmic imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reactions due to indocyanine green. Hope-Ross, M., Yannuzzi, LA., Gragoudas, ES., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40499746/

Indocyanine green fluorescence angiography-guided ... ICG-guided arthroscopic RCR showed greater improvement in pain VAS at 6 months postoperatively compared to the conventional RCR group and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1058274625004355

Indocyanine green (ICG) fluorescence angiography-guided ... ICG-guided arthroscopic rotator cuff repair showed greater improvement in pain VAS at 6 months postoperatively compared to the conventional RCR group.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274625004355

Indocyanine green fluorescence angiography-guided ... Patients with small-sized to medium-sized rotator cuff tears who underwent RCR using ICG showed positive outcomes in terms of functional ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6444017/

Intraoperative evaluation of blood flow for soft tissues in ... We hypothesized that Indocyanine green (ICG) fluorescence angiography can be used to evaluate the blood flow of the rotator cuff tendon in arthroscopic surgery.

5. withpower.com withpower.com/trial/phase-1-rotator-cuff-injuries-2021-bcb97

Indocyanine Green Imaging for Rotator Cuff Surgery Indocyanine Green (ICG) has been safely used in patients for visualization purposes and has real potential for identifying vascularity in arthroscopic surgical ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05179941

Subscapularis Indocyanine Green Perfusion Pilot Study (ICG) The Purpose of this pilot study is to evaluate the feasibility of open wide-field imaging of indocyanine green ingress and egress during total shoulder ...

7. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(23)00338-9/fulltext

Indocyanine Green Fluorescence-Guided Knee Arthroscopy In this Technical Note, the author applied ICG fluorescence-guided surgery to knee arthroscopy to evaluate blood supply to the meniscus and intra-articular ...