Using a dye to improve surgery for children's solid tumors
The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid
This study is testing if a special dye can help doctors find and remove solid tumors in children more accurately during surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 1 Day to 45 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT04492735 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of indocyanine green (ICG) dye to enhance the accuracy of identifying and removing primary solid tumors and their lung metastases in pediatric patients. It is a prospective feasibility study involving children diagnosed with solid malignancies who are scheduled for surgical resection. The study aims to assess the diagnostic accuracy of ICG through pathologic correlation and to monitor both short-term and long-term survival outcomes. Patients will be informed about the study by their oncologist and will need to provide consent for participation.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients with newly diagnosed solid tumors or metastatic lesions requiring surgical resection.
Not a fit: Patients who are pregnant, breastfeeding, or have iodine allergies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical interventions and improved survival rates for children with solid malignancies.
How similar studies have performed: While the use of ICG in adult populations has shown promise, this application in pediatric solid malignancies is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients with newly diagnosed solid, primary malignancies or their related metastatic lesions. Diagnosis of primary or metastatic malignancy will be made by combination of: 1. Clinical evaluation and physical exam 2. Radiologic study including ultrasound, CT scan, and/or MRI 3. Pathologic diagnosis after biopsy Exclusion Criteria: 1. Those patients and parents/guardians unwilling to provide consent/assent. 2. Pregnant and/or women who are breast feeding. 3. Patients with Iodine allergies
Where this trial is running
Cincinnati, Ohio
- Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Erin Watters
- Email: erin.watters@cchmc.org
- Phone: 513-803-7024
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.