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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Rotator cuff re-tear is a common delayed complication of arthroscopic rotator cuff repair. This process of re-tear is multifactorial and there has not been any readily identifiable perioperative measure that is predictive of subsequent rotator cuff failure. There have been no human studies looking at intraoperative assessment of rotator cuff vascularity, nor the predictive value that vascularity may have for rotator cuff re-tear. Indocyanine Green (ICG) has been safely used in patients for visualization purposes and has real potential for identifying vascularity in arthroscopic surgical patients. The aim of this study is to establish a standard dosing protocol for ICG in the arthroscopic visualization of rotator cuff vascularity.

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 Indocyanine Green (ICG) safe for use in humans?

Indocyanine Green (ICG) has been used safely for over 30 years in tests for heart and liver function, but there are known adverse reactions. Some cases report severe reactions during heart surgery and eye toxicity after cataract surgery, so while generally safe, there are risks to be aware of. ^{1 2 3 4 5}

How does the drug Indocyanine Green (ICG) differ from other treatments for rotator cuff surgery?

Indocyanine Green (ICG) is unique because it is a fluorescent dye used during surgery to provide real-time imaging of blood flow in tissues, helping surgeons assess the health of the rotator cuff tendon. This approach is different from traditional methods that do not offer such detailed visualization of blood flow during the procedure. ^{1 6 7 8 9}

Research Team

Kirk Campbell, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

I am between 18 and 79 years old.

Exclusion Criteria

Patient has a documented allergy to iodides

I am either younger than 18 or older than 79.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Indocyanine Green Fluorescence Angiography Is Sensitive for Predicting Postoperative Wound Complications in Soft-Tissue Sarcoma Surgery. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Severe hemodynamic instability after indocyanine green injection during off-pump coronary artery bypass grafting: A case report. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Indocyanine green toxicity of the retina after cataract surgery: a case report. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Should Indocyanine green should be used to facilitate removal of the internal limiting membrane in macular hole surgery. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Adverse reactions due to indocyanine green. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Intraoperative evaluation of blood flow for soft tissues in orthopaedic surgery using indocyanine green fluorescence angiography: A pilot study. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Use of indocyanine green angiography in oncological and reconstructive breast surgery]. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Indocyanine Green in Bariatric Surgery: a Systematic Review. [2023]

9. Spain 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. [2022]