RecruitingPhase 1NCT06235125

Safety and Feasibility of Intraoperative Visualization With Cytalux in Children

A Pilot Study of Near-Infrared Imaging Using the Novel Imaging Agent Cytalux for Adolescent Patients With Metastatic Osteosarcoma Undergoing Pulmonary Metastasectomy


Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Enrollment

10 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Pediatric subjects aged 6-17 with biopsy confirmed cancer and imaging findings suspicious for pulmonary metastatic disease scheduled to undergo pulmonary metastasectomy via and open or minimally invasive approach.


Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a fluorescent dye called Cytalux in children aged 6–17 who are having lung surgery to remove suspected cancer tumors (metastases). The dye helps surgeons see tumors more clearly during the operation. **You may be eligible if...** - Your child is between 6 and 17 years old and weighs at least 20 kg - Your child has a confirmed diagnosis of osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, synovial sarcoma, hepatoblastoma, Wilms tumor, or other soft tissue sarcoma - Scans have shown suspected lung metastases (with at least one nodule 4 mm or larger), and lung surgery is planned - A parent or guardian is willing to provide written consent **You may NOT be eligible if...** - Your child has had an allergic reaction to indocyanine green (a similar dye) before - Your child has a medical condition that could make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCytalux

Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL


Locations(1)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, United States

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NCT06235125


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