Recruiting
Phase 1

ICG Fluorescence

Sponsor:

Henry Ford Health System

Code:

NCT07793266

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 - 70+

Healthy Volunteers: Not accepted

Interventions

Intravenous administration of indocyanine green (SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose)

Intravenous administration of indocyanine green (SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose)

Intravenous administration of indocyanine green (SPY Agent Green) 4 mL of SPY Agent Green (10 mg dose)

Intravenous administration of indocyanine green (SPY Agent Green)5 mL of SPY Agent Green (12.5 mg dose)

Study Details

Brief summary:

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.

Conditions

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

Study ID

NCT07793266

Start date

Jun 1, 2026

Status verified date

Aug, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients undergoing knee arthroscopy with a HFH Orthopaedic surgeon

  • Patients must be within ages of 14-89. Patient ages 14-17 will be included to capture an important sporting demographic who sustain ACL injuries which would stand to benefit from this intervention if successful.
  • Have signed an approved informed consent form for the study.
  • Be willing to comply with the protocol

Exclusion Criteria:

  • Patient is less than 14 years of age or greater than 89 years of age

  • Patients who have had iodide-based radiology studies within the last seven (7) days prior to surgery
  • Previous surgical repair of targeted surgical area
  • Known allergy or history of adverse reaction to SPY Agent Green, ICG,
  • Subjects who have participated in another investigational study within 30 days prior to surgery.
  • Pregnant or lactating subjects.
  • Subjects who, in the Investigator's opinion, have any medical condition that may make the subject a poor candidate for the investigational procedure, or interfere with the interpretation of study results.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

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)

Interventions

Intravenous administration of indocyanine green (SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose)

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)

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)

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)

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Maxim A Jani, BS

2488240579mjani1@hfhs.org

Locations

Henry Ford Center for Athletic Medicine

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Maxim A Jani, BS

2488240579mjani1@hfhs.org

More Information

Sponsor

Henry Ford Health System

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-08-28.