A Pilot Study of Near-Infrared Imaging Using the Novel Imaging Agent Cytalux for Adolescent Patients With Metastatic Osteosarcoma Undergoing Pulmonary Metastasectomy
Pediatric subjects aged 6-17 with biopsy confirmed cancer and imaging findings suspicious for pulmonary metastatic disease scheduled to undergo pulmonary metastasectomy via and open or minimally invasive approach.
• Patients 6-17 years of age at the time of study enrollment
• Willingness of research participant or legal guardian/representative to give written informed consent
• Willingness of patients (subjects) age 12-17 to provide written adolescent assent
• Patient weight greater than or equal to 20 kg
• Histologically confirmed diagnosis of osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor or other non-rhabdomyosarcoma soft tissue sarcoma
• Imaging findings highly suspicious for pulmonary metastatic disease based on CT, PET-CT or other imaging and warranting pulmonary surgery based on the judgment of the treating team. At least one nodule ≥4mm measured by preoperative imaging.
• Female (assigned female at birth) participant is not pregnant and agrees to an acceptable form of contraception from the time of consent through 30 days after study intervention. Confirmed abstinence is an acceptable form of contraception.
• Female (assigned female at birth) participant must agree to not donate ova from time of consent until 30 days after study intervention
• Male (assigned male at birth) participant must agree to not donate sperm from time of consent until 30 days after study intervention.