ICG Fluorescence in Knee Arthroscopy Study

Conditions

• To Assess the Feasibility, Visualization Capability, and Optimal Dosing of ICG Fluorescence Imaging for Intraoperative Assessment of Knee Tissue Perfusion

Eligibility Criteria

Sex

ALL

Age

14 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• Intravenous administration of indocyanine green (SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose) — COMBINATION_PRODUCT
  Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose). Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues. Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.
• Intravenous administration of indocyanine green (SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose) — COMBINATION_PRODUCT
  Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose). Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues. Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.
• Intravenous administration of indocyanine green (SPY Agent Green) 4 mL of SPY Agent Green (10 mg dose) — COMBINATION_PRODUCT
  Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 4 mL of SPY Agent Green (10 mg dose). Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues. Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.
• Intravenous administration of indocyanine green (SPY Agent Green)5 mL of SPY Agent Green (12.5 mg dose) — COMBINATION_PRODUCT
  Participants undergoing knee arthroscopy will receive a single intraoperative intravenous dose of indocyanine green (ICG; SPY Agent Green) 5 mL of SPY Agent Green (12.5 mg dose). Following administration, surgeons will use a near-infrared fluorescence-capable arthroscopy system (AIM/1788 platform) to visualize and record perfusion of intra-articular knee structures, including tendons and synovial tissues. Fluorescence presence, time to visualization, and signal duration will be documented intraoperatively, after which the procedure will continue according to standard surgical care.

Study Details

The purpose of this study is to first evaluate whether ICG fluorescence angiography can be used to evaluate blood flow of the anterior cruciate ligament (ACL), tendons, and knee structures during an arthroscopic surgery. The secondary purpose is to evaluate differences in the blood flow in patients with varying grades of ACL tears. To determine optimal intravenous dose of SPY Agent Green and time to visualize fluorescence in tendons and structures intraoperatively during arthroscopic surgery (if primary objective is deemed yes). We hypothesize that ICG will be effective in evaluating blood flow in patients undergoing knee arthroscopy.

Key Dates

First listed

Aug 28, 2026

Start date

Jun 1, 2026

Status verified

Aug 2026

Primary completion

Mar 1, 2027

Completion

Mar 1, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: 2 mL of SPY Agent Green (5.0 mg dose)
  Cohort #1: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 2 mL of SPY Agent Green (5.0 mg dose)
• Experimental: 3 mL of SPY Agent Green (7.5 mg dose)
  Cohort #2: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 3 mL of SPY Agent Green (7.5 mg dose)
• Experimental: 4.0 mL of SPY Agent Green (10.0 mg dose)
  Cohort #3: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 4.0 mL of SPY Agent Green (10.0 mg dose)
• Experimental: 5.0 mL of SPY Agent Green (12.5 mg dose)
  Cohort #4: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 5.0 mL of SPY Agent Green (12.5 mg dose)

Primary Outcome Measure

Fluorescence signal [ Time Frame: From enrollment to first follow up appointment. ]

Central Contacts

• Maxim A Jani, BS
  2488240579
  [email protected]

Locations (1)

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