Phase 1 Lung Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Children and teenagers between 6 and 17 years old at the time of joining the study
- The patient or their parent/legal guardian must be willing to sign a written consent form
- Patients aged 12–17 must be willing to sign their own written agreement (called adolescent assent)
- The patient must weigh at least 20 kg (about 44 pounds)
- The patient must have a confirmed diagnosis (through tissue testing) of one of these cancers: osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor, or certain other soft tissue sarcomas
- Scans (such as CT or PET-CT) must show signs strongly suggesting that cancer has spread to the lungs, with at least one spot measuring 4mm or larger, and the treating medical team must have recommended lung surgery
- Female patients (assigned female at birth) must not be pregnant and must agree to use an acceptable form of contraception from the time of consent until 30 days after the study procedure (confirmed abstinence is acceptable)
- Female patients (assigned female at birth) must agree not to donate eggs from the time of consent until 30 days after the study procedure
- Male patients (assigned male at birth) must agree not to donate sperm from the time of consent until 30 days after the study procedure, and must commit to an acceptable form of contraception (confirmed abstinence is acceptable)
Who may not be able to join:
- Patients with any medical condition that the study doctors believe could put their safety at risk
- Patients with a history of severe allergic reactions (anaphylaxis) to products containing indocyanine green, or a history of unexplained severe allergic reactions in general
- Patients with a known allergy to any ingredient in the study drug Cytalux™ (pafolacianine)
- Patients with psychological, family, social, or location-related challenges that might make it difficult to follow the study schedule or attend follow-up appointments
- Patients with significantly reduced kidney function, as measured by a specific blood test (confirm with trial site)
- Patients with significantly reduced liver function, based on abnormal results on certain liver blood tests (confirm with trial site)
- Patients who are unable or unwilling to stop taking folate, folic acid, or supplements containing folate at least 48 hours before receiving the study drug
- Patients who previously had a serious reaction to Cytalux and are being considered for re-enrollment for surgery on the other side
- Patients whose 12th or 18th birthday would fall during the period of study participation
- Male patients (assigned male at birth) who are unwilling or unable to commit to an acceptable form of contraception from consent through 30 days after the study procedure
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Timothy Lautz, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Phone: 312-227-4210
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Sensitivity of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification; False-Positive Rate of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.