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

A vizsgálat adatai

Ki végzi

Abramson Cancer Center at Penn Medicine

Azonosító

NCT07658768

A regiszteradat frissítve

2026. november 2.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 1. Male and female children (12 - 17 years of age) with a primary diagnosis, or a high clinical suspicion of a solid tumor with metastasis to the lung warranting surgery based on CT/PET or other imaging 2. Are scheduled to undergo surgical resection for suspected metastasis 3. Female subjects of childbearing potential (including those less than 2 years postmenopausal) agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after infusion of ICG. Male subjects who are are sexually active (and capable of producing sperm) with a partner that could become pregnant, must agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after infusion of ICG.

Kizáró feltételek: 1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject 2. History of anaphylactic reactions to ICG. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation 3. A positive serum pregnancy test at screening for female subjects of childbearing potential. Note that subjects with a positive pregnancy test on the day of infusion will be discontinued from study and will not receive the study drug; Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule 5. Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase (ALP), or >2x ULN for total bilirubin except in subjects with Gilbert's syndrome. *For subjects with Gilbert's syndrome, total bilirubin levels exceeding 3 mg/dL will be excluded.* 6. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug 7. History of uncontrolled hypertension. (e.g., history of an emergency room [ER] admission for hypertensive crisis or ≥ 3 BP medications) 8. Known sensitivity to fluorescent light.

ClinicalTrials.gov NCT07658768