Recruiting
Early Phase 1

Indocyanine Green

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT07658768

Conditions

Sarcoma Metastatic

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

ICG INFUSION 5MG/KG

Study Details

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

Study ID

NCT07658768

Start date

Jul 29, 2026

Status verified date

Oct, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

ICG INFUSION 5MG/KG

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

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital of Philadelphia

Recruiting

Phildelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Suzanne P MacFarland, MD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Keywords

  • metastasis
  • sarcoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.