ICG Fluorescence in Knee Arthroscopy Study
25 de agosto de 2026 actualizado por: Vasilios Moutzouros, Henry Ford Health System
Intraoperative Evaluation of Blood Flow for Knee Arthroscopy Using Indocyanine Green Fluorescence Angiography
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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
- Producto combinado: Intravenous administration of indocyanine green (SPY Agent Green) 2 mL of SPY Agent Green (5.0 mg dose)
- Producto combinado: Intravenous administration of indocyanine green (SPY Agent Green) 3 mL of SPY Agent Green (7.5 mg dose)
- Producto combinado: Intravenous administration of indocyanine green (SPY Agent Green) 4 mL of SPY Agent Green (10 mg dose)
- Producto combinado: Intravenous administration of indocyanine green (SPY Agent Green)5 mL of SPY Agent Green (12.5 mg dose)
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Maxim A Jani, BS
- Número de teléfono: 2488240579
- Correo electrónico: mjani1@hfhs.org
Ubicaciones de estudio
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Reclutamiento
- Henry Ford Center for Athletic Medicine
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Contacto:
- Maxim A Jani, BS
- Número de teléfono: 2488240579
- Correo electrónico: mjani1@hfhs.org
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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) |
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) |
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) |
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) |
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fluorescence signal
Periodo de tiempo: 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.
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From enrollment to first follow up appointment.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Vasilios Moutzouros, MD, Henry Ford Health System
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2026
Finalización primaria (Estimado)
1 de marzo de 2027
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
25 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de agosto de 2026
Publicado por primera vez (Actual)
28 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 17358-09
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
IPD will not be shared because participant-level data are maintained on secure, access-restricted systems for use by authorized study personnel only and will be destroyed following publication or six months of inactivity, in accordance with the study protocol.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .