Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 14 to 89

See how well ICG fluorescence can show knee tissue blood flow during arthroscopy

Official title: Intraoperative Evaluation of Blood Flow for Knee Arthroscopy Using Indocyanine Green Fluorescence Angiography

Run by Henry Ford Health System · NCT07793266 · Data updated 2026-11-12

This study tests whether injecting a dye called ICG can help doctors see blood flow in knee tissues during arthroscopic knee surgery, including different ACL tear severities.

Quick facts

PhasePhase 1
Study typeInterventional
Ages14 Years to 89 Years
SexAll
Enrollment40 (estimated)
SponsorHenry Ford Health System
Academic / other
Locations1 site (Detroit, Michigan)
StatusRecruiting
StartedJune 1, 2026
Main results expectedMarch 1, 2027
Study endsMarch 1, 2027
Registry record updatedAugust 28, 2026
Trial IDNCT07793266 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Candidates are patients aged 14–89 undergoing knee arthroscopy at Henry Ford Center for Athletic Medicine who can consent and comply with the protocol.

Probably not a fit

Patients with iodide allergy, recent iodinated studies, prior targeted surgery, pregnancy, or other safety exclusions may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase interventional study evaluates the feasibility and visualization capability of indocyanine green (ICG) fluorescence imaging to assess tissue perfusion in the knee during arthroscopy. It compares fluorescence visualization across ACL tear grades and aims to identify an optimal ICG dose and timing for intraoperative use. Participants are adults and adolescents undergoing knee arthroscopy who meet consent and safety criteria. Four dose levels of SPY Agent Green (5, 7.5, 10, and 12.5 mg) are tested to determine intraoperative visualization kinetics. Safety and feasibility outcomes are collected to inform future larger studies.

Why it matters

Potential benefit: If successful, this approach could improve real-time assessment of knee tissue blood flow during surgery, potentially guiding interventions.

How similar studies have gone: Previous uses of ICG fluorescence in orthopedic surgery have shown feasibility for imaging perfusion, supporting this exploratory approach in the knee.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Henry Ford Center for Athletic Medicine
    Detroit, Michigan, United States
    Recruiting

Study contacts

  • Principal investigator: Vasilios Moutzouros, MD — Henry Ford Health System
  • Study coordinator: Maxim A Jani, BS
  • Email: mjani1@hfhs.org
  • Phone: 2488240579

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.