Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy

NCT04340752 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 18-01995
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Optimal dosing of an intravenous fluorescence solution (ICG) for arthroscopic evaluation of rotator cuff vascularity

  Advanced Imaging Modality (AIM) arthroscopy videos for each dosing arm will be collected and five signal intensity readings will be collected from the rotator cuff within each video. The ability to visualize rotator cuff vascularity will be graded by surgeons blinded to the ICG dosing using a 5 point Likert scale where 1 indicates worst visibility and 5 indicates best visibility. Post-hoc ANOVA analysis of surgeons' responses to determine what dose of ICG is optimal for the surgery.

  up to 6 months post operative visit

Study Arms (3)

Group 1:ICG 7.5 mg

EXPERIMENTAL

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.

Drug: Indocyanine Green

Group 2:ICG 12.5 mg

EXPERIMENTAL

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.

Drug: Indocyanine Green

Group 3: ICG 25 mg

EXPERIMENTAL

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.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

ICG is an injectable fluorescent pigment that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision. The ICG will not affect the course of the operative or postoperative period, and will be injected intravenously prior to the actual repair

Group 1:ICG 7.5 mg; Group 2:ICG 12.5 mg; Group 3: ICG 25 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients has full or partial thickness rotator cuff tear and is scheduled to undergo arthroscopic rotator cuff repair
• Patient is at least 18 years of age and less than 80 years of age

You may not qualify if:

• Patient is less than 18 years of age or greater than 79 years of age
• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kirk Campbell

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 9, 2020
• Study Start: January 27, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to kirk.campbell@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)