To Assess the Feasibility, Visualization Capability, and Optimal Dosing of ICG Fluorescence Imaging for Intraoperative Assessment of Knee Tissue Perfusion
Conditions
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.
Interventions
COMBINATION_PRODUCTIntravenous 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.
COMBINATION_PRODUCTIntravenous 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.
COMBINATION_PRODUCTIntravenous 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.
COMBINATION_PRODUCTIntravenous 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.
Sponsors
Henry Ford Health System
Stryker Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The only think that will be masked to the patient is the dose of the ICG dye that is being administered.
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
Eligibility
Sex/Gender
ALL
Age
14 Years to 89 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescence signal | From enrollment to first follow up appointment. | To determine if a fluorescence signal is present in knee structures during arthroscopic surgery after an intravenous administration of SPY Agent Green is given. |
Countries
United States
Contacts
CONTACTMaxim A Jani, BS
PRINCIPAL_INVESTIGATORVasilios Moutzouros, MD
Henry Ford Health System
Outcome results
None listed