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NCT06235125RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 5 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
10 (estimated)
First submitted
6 Jan 2024
Start date
8 Apr 2024
Primary completion date
31 Aug 2026
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
NCT number
NCT06235125

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 10
  • From 8 Apr 2024 to the primary completion date, 31 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient unable or unwilling to discontinue folate, folic acid, or folate-containing supplements 48 hours before study drug administration
  • 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).

Other illness

  • Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
  • 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.
  • History of allergy to any of the components of CYTALUX™ (PAFOLACIANINE) INJECTION
  • Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule

Lab values

  • Impaired renal function defined as eGFR\< 50 mL/min/1.73m2
  • 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.

Other

  • Participants will be excluded if their 12th or 18th birthday would occur during study participation
  • 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.

Who the study is looking for

  • Patients 6-17 years of age at the time of study enrollment
  • Willingness of research participant or legal guardian/representative to give written informed consent
  • Willingness of patients (subjects) age 12-17 to provide written adolescent assent
  • Patient weight greater than or equal to 20 kg
  • Histologically confirmed diagnosis of osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor or other non-rhabdomyosarcoma soft tissue sarcoma
  • 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.
  • 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.
  • Female (assigned female at birth) participant must agree to not donate ova from time of consent until 30 days after study intervention
  • Male (assigned male at birth) participant must agree to not donate sperm from time of consent until 30 days after study intervention.

Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ann & Robert H. Lurie Children's Hospital
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.