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

NCT07658768 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 25-023410
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

metastasis; sarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity of INR

  1 year

Study Arms (1)

Single Dose 5mg/kg

EXPERIMENTAL

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

Interventions

ICG INFUSION 5MG/KG DRUG

Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery.

Single Dose 5mg/kg

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

MeSH Terms

Conditions

Neoplasm Metastasis; Sarcoma

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Central Study Contacts

Peter Mattei, MD

CONTACT

(215)-590-2730; mattei@email.chop.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06