Pilot Study of TumorGlow for Intraoperative Molecular Imaging of Sarcoma Metastases to the Lungs in Pediatric Patients
NCT07658768 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-06-22
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.
Conditions
- Sarcoma Metastatic
Interventions
- DRUG
-
ICG INFUSION 5MG/KG
Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery.
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2027-05-01
- Completion
- 2027-05-01
- FDA Drug
- Yes
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