Home › NCT07793266

ICG Fluorescence in Knee Arthroscopy Study

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

Who can join

Ages 14 to 89 · All sexes

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.

About the study

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.

What is being tested

• Intravenous administration of indocyanine green (SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose) (combination product)
• Intravenous administration of indocyanine green (SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose) (combination product)
• Intravenous administration of indocyanine green (SPY Agent Green) 4 mL of SPY Agent Green (10 mg dose) (combination product)
• Intravenous administration of indocyanine green (SPY Agent Green)5 mL of SPY Agent Green (12.5 mg dose) (combination product)

Sponsor: Henry Ford Health System · Participants: 40 · Started: Jun 1, 2026

Contact the study team

• Maxim A Jani, BS · Phone: 2488240579

Official record on ClinicalTrials.gov — NCT07793266

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.