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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoma Metastatic
• Intervention / Treatment: Drug: ICG INFUSION 5MG/KG

Detailed Description

This is a phase 1 single dose, open-label study to determine the safety of a single 5 mg/kg dose of ICG (TumorGlow) used with Near Infrared (NIR) fluorescent for pediatric subjects with suspected metastatic sarcoma to the lung scheduled to undergo thoracic surgery per CT/PET or other imaging based on standard of care.

Following the screening visit to confirm eligibility, subject assent and parental/legal guardian consent for enrollment will be obtained prior to commencement of any study procedures. The screening period will be up to 60 days prior to ICG infusion. All subjects enrolled will be infused with 5 mg/kg ICG intravenously up to 5-days prior to the planned surgery (Day 0).

After ICG infusion is completed (Day 0), subjects during the surgery will undergo white light evaluation and/or palpation, and the number and the location of all suspicious nodules and lesions identified in this step will be recorded as such following the study procedure guideline as described in  (Day 1). Following white light assessment, but prior to any surgical removal of lesions/nodules, subjects will undergo assessment with NIR fluorescent light imaging to localize any lesions or nodules.

All identified lesions will be removed as determined by the surgeon. All removed lesions identified either using white light, NIR imaging or both will be documented as such and examined back table for fluorescence under NIR imaging including margin status. Positive margins are defined as fluorescent areas identified within (less than or equal to) 5mm of the inside staple line by back table measurement. Following the resection and prior to closing the subject, the field will be illuminated with the imaging system again to detect and remove any remaining fluorescence positive nodules. All specimens removed after the back table examination will be sent to pathology for evaluation including margin status by a pathologist that is blinded to the fluorescent status of lesions or nodules.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Peter Mattei, MD; Phone Number: (215)-590-2730; Email: mattei@email.chop.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

  4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Dose 5mg/kg; Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	To assess the safety and tolerability of intravenously infusion of a single dose 5 mg/kg of ICG; 2. To assess the safety and tolerability of using high dose (5 mg/kg) ICG used with Near Infrared (NIR) fluorescent imaging when used with ICG in subjects undergoing pulmonary metastasectomy. Safety will be assessed by the incidence of AEs and SAEs coded using MedDRA. Results will be summarized as the number and percentage of participants with events, categorized by preferred term, system organ class, severity grade, attribution, and timing relative to infusion and surgery. AE rates will be reported with one-sided 90% exact confidence intervals and compared against a 25% unacceptable safety threshold.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of INR	The following secondary efficacy endpoints are only defined for FAS subjects, i.e., subjects undergoing NIR fluorescent imaging with ICG for the detection of primary nodules and/or synchronous lesions	1 year

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: metastasis; sarcoma
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Neoplastic Processes; Neoplasms, Connective and Soft Tissue; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Sarcoma
• Other Study ID Numbers: 25-023410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No