Using Indocyanine Green to help remove tumors in children
Indocyanine Green (ICG) Guided Tumor Resection
This study is testing if a special dye called Indocyanine Green can help doctors see and remove tumors more accurately during surgery in children with cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT04084067 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Indocyanine Green (ICG) in identifying neoplastic diseases during surgical procedures for pediatric patients. It involves administering ICG intravenously before surgery, followed by real-time near-infrared imaging to visualize tumors and their margins. The goal is to improve the accuracy of tumor resections by using advanced imaging techniques to ensure complete removal of cancerous tissues. The trial will document the imaging process and measure residual fluorescence post-surgery to assess the completeness of the resection.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients with primary or relapsed solid tumors or lymphoma requiring surgical excision.
Not a fit: Patients with benign tumors, brain tumors, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance surgical outcomes for children with solid tumors by ensuring more precise tumor removal.
How similar studies have performed: Other studies have shown success with ICG in adult populations, but this application in pediatric oncology is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions. Exclusion Criteria: * Subjects with a history of iodide allergies. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. * Patients with benign pathology. * Patients with brain tumors. * Pregnant female. * Patients with unilateral Wilms Tumor.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Lindsay Talbot, MD — St. Jude Children's Research Hospital
- Study coordinator: Lindsay Talbot, MD
- Email: referralinfo@stjude.org
- Phone: 888-226-4343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.