Using Cytalux for better cancer surgery in children
A Pilot Study of Near-Infrared Imaging Using the Novel Imaging Agent Cytalux for Adolescent Patients With Metastatic Osteosarcoma Undergoing Pulmonary Metastasectomy
This study is testing if a special imaging agent called Cytalux can help doctors find and remove lung tumors more effectively during surgery in children with cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06235125 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and feasibility of using Cytalux, a tumor imaging agent, during surgery to remove lung metastases in pediatric patients aged 6-17 with confirmed cancer. The study aims to enhance fluorescence-guided surgery by targeting tumor-specific receptors, potentially improving the detection of small metastatic nodules. Participants will undergo pulmonary metastasectomy, and the effectiveness of Cytalux in improving surgical outcomes will be evaluated. The trial builds on previous findings in adults, suggesting that this approach could be beneficial for children as well.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-17 with specific types of cancer and imaging findings indicating pulmonary metastasis.
Not a fit: Patients without confirmed cancer or those not exhibiting pulmonary metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and better cancer management for pediatric patients with metastatic disease.
How similar studies have performed: Previous studies in adults have shown success with similar fluorescence-guided surgical techniques, suggesting potential applicability in the pediatric population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients 6-17 years of age at the time of study enrollment 2. Willingness of research participant or legal guardian/representative to give written informed consent 3. Willingness of patients (subjects) age 12-17 to provide written adolescent assent 4. Patient weight greater than or equal to 20 kg 5. Histologically confirmed diagnosis of osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor or other non-rhabdomyosarcoma soft tissue sarcoma 6. Imaging findings highly suspicious for pulmonary metastatic disease based on CT, PET-CT or other imaging and warranting pulmonary surgery based on the judgment of the treating team. At least one nodule ≥4mm measured by preoperative imaging. 7. Female (assigned female at birth) participant is not pregnant and agrees to an acceptable form of contraception from the time of consent through 30 days after study intervention. Confirmed abstinence is an acceptable form of contraception. 8. Female (assigned female at birth) participant must agree to not donate ova from time of consent until 30 days after study intervention 9. Male (assigned male at birth) participant must agree to not donate sperm from time of consent until 30 days after study intervention. 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 products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will also be excluded. 3. History of allergy to any of the components of CYTALUX™ (PAFOLACIANINE) INJECTION 4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule 5. Impaired renal function defined as eGFR\< 50 mL/min/1.73m2 6. Impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>2x ULN for total bilirubin except in subjects with Gilbert's syndrome. 7. Patient unable or unwilling to discontinue folate, folic acid, or folate-containing supplements 48 hours before study drug administration 8. History of drug-related serious adverse event with prior Cytalux administration will be an exclusion for re-enrollment for contralateral surgery (see section 5.7). 9. Participants will be excluded if their 12th or 18th birthday would occur during study participation 10. Male sex at birth and commitment to acceptable form of contraception from time of consent through 30 days after study intervention with confirmed abstinence as an acceptable form of contraception as an inclusion criterion.
Where this trial is running
Chicago, Illinois
- Ann & Robert H. Lurie Children's Hospital — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Timothy Lautz, MD — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Timothy Lautz, MD
- Email: tlautz@luriechildrens.org
- Phone: 312-227-4210
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.