TumorGlow use during surgery to see sarcoma lung metastases in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, open-label trial to assess the safety of a one-time intravenous dose of indocyanine green (ICG) with near-infrared imaging in children with suspected sarcoma metastasis to the lungs who are scheduled for thoracic surgery. Participants receive 5 mg/kg ICG up to five days before surgery, followed by standard surgical resection the next day with white-light and NIR imaging to localize lesions. All identified lesions are removed and analyzed to determine fluorescence margins and imaging performance. The study focuses on safety and collects initial data on how well the imaging helps locate and resect metastatic lesions.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital of Philadelphia
  Phildelphia, Pennsylvania, United States Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Metformin plus standard first-line therapy for advanced soft tissue sarcoma

  This trial tests whether adding metformin to standard first-line systemic treatment helps people with previously untreated advanced or metastatic soft tissue sarcoma.

  Recruiting at 2 sites Phase 2 Wake Forest University Health Sciences · Charlotte, North Carolina and 1 other locations · NCT07291297

• Sequential CD146- and HER2-targeted CAR T-cell therapy for advanced sarcoma

  This treatment will test whether giving a patient's own CAR T cells that target CD146 and HER2, one after the other, can shrink tumors in children and adults with relapsed or refractory advanced sarcoma.

  Recruiting Phase 1/2 Essen Biotech · Beijing, Beijing Municipality · NCT07066982

• Zanzalintinib treatment for advanced leiomyosarcoma

  This study is testing if a new medication called zanzalintinib can help people with advanced leiomyosarcoma live longer without their cancer getting worse.

  Recruiting Phase 2 Northwestern University · Chicago, Illinois · NCT06571734

• Evaluating a digital care plan for patients with advanced sarcomas on second-line treatment

  This study is testing if a new digital care plan can help people with advanced sarcomas on second-line treatment have fewer severe side effects compared to the usual care they receive.

  Recruiting at 7 sites Centre Oscar Lambret · Lyon, Auvergne-Rhône-Alpes and 10 other locations · NCT06211257

• Impact of digital health support on symptom and side-effect management for advanced/metastatic sarcoma

  A digital health platform is being tested to help adults with advanced or metastatic sarcoma manage symptoms and side effects while receiving standard cancer care.

  Recruiting at 11 sites CareAcross · Athens and 10 other locations · NCT07642375

• Targeted radiation therapy for young patients with metastatic sarcoma

  This study is testing if a special type of radiation therapy can help young patients with metastatic sarcoma live longer and have fewer health issues compared to those who don’t receive it.

  Recruiting at 3 sites Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Washington D.C., District of Columbia and 2 other locations · NCT06796543

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.