drugset / Trial / NCT07658768

Pilot Study of TumorGlow for Intraoperative Molecular Imaging of Sarcoma Metastases to the Lungs in Pediatric Patients

NCT07658768

Phase 0 Not yet recruiting 20 enrolled Abramson Cancer Center at Penn Medicine
NaSingle-groupOpen-labelTreatment

Summary

Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery. Then, during the surgical procedure the next day, the subjects will undergo standard-of-care surgery. During the surgery, the fluorescence from the tumor will be used to localize lesions and ensure the entire tumor has been removed, as well as locate any un-expected tumors. The goal of this protocol is to evaluate safety and collect initial efficacy data using indocyanine green with NIR fluorescence imaging in a pediatric patient population undergoing pulmonary metastatectomy.

Timeline

Start
2026-09-01
Primary completion
2027-05-01
Completion
2027-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Indocyanine Green Diagnostic / imaging agent 5 mg/kg Intravenous

Indications