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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 14 Years and 89 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Approximately 40 subjects will be enrolled at 1 center in North America. Dose cohorts have been identified based on previous pre-clinical work and clinical publications, however, during the study those cohorts may be modified by the company and PI to adjust based on image sensitivity or fluorescence signal, never to exceed maximum daily dose of SPY Agent Green at 2.0 mg / kg. 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) 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) 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) Cohort #4: up to 10 subjects but may be modified based on fluorescence signal after 3 subjects at the discretion of PI. 5.0 m
Primary Purpose
Diagnostic
Masking
None (Open Label)
Masking Description
The only think that will be masked to the patient is the dose of the ICG dye that is being administered.

Arm Groups

ArmDescriptionAssigned Intervention
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)
  • Combination Product: 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.
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)
  • Combination Product: 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.
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)
  • Combination Product: 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.
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)
  • Combination Product: 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.

Recruiting Locations

Henry Ford Center for Athletic Medicine
Detroit, Michigan 48202
Contact:
Maxim A Jani, BS
2488240579
mjani1@hfhs.org

More Details

Status
Recruiting
Sponsor
Henry Ford Health System

Study Contact

Maxim A Jani, BS
2488240579
mjani1@hfhs.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.