RecruitingPhase 1NCT06235125
Official study title

Safety and Feasibility of Intraoperative Visualization With Cytalux in Children

Study 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.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedCytalux

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 5, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Ann & Robert H Lurie Children's Hospital of Chicago

Study sponsor

01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Phase 1
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Interventions being studied
Drug: Cytalux
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Ann & Robert H. Lurie Children's HospitalChicago, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 5, 2026. Always confirm current availability with the study team.

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