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RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "This is a pilot study in pediatric subjects aged 6-17 with biopsy confirmed cancer and imaging findings suspicious for pulmonary metastatic disease scheduled to undergo pulmonary metastasectomy via an open or minimally invasive approach."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether using Cytalux to help see cancer during surgery is safe and practical in children. It is for children ages 6–17 with cancer confirmed by a tissue test and scans suggesting it has spread to the lungs, who are scheduled for surgery to remove it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 6–17 years old when joining the study.
  • The patient or legal guardian must give written consent. Patients ages 12–17 must also give written agreement.
  • Weigh at least 20 kg (about 44 pounds).
  • Have a tissue test confirming one of these cancers: osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor, or another soft tissue sarcoma that is not rhabdomyosarcoma.
  • Have scans that strongly suggest cancer has spread to the lungs, including at least one lump measuring 4 mm or more. The care team must recommend lung surgery.
  • If assigned female at birth, not be pregnant and agree to use accepted birth control from consent until 30 days after the study treatment. Not having sex is accepted.
  • If assigned female at birth, agree not to donate eggs from consent until 30 days after the study treatment.
  • If assigned male at birth, agree not to donate sperm from consent until 30 days after the study treatment.

Who can't join

  • Have a health condition that the study doctors believe could make participation unsafe.
  • Have had a severe allergic reaction to indocyanine green, a dye used for imaging, or a severe allergic reaction with no known cause. An allergy to any Cytalux ingredient also rules out joining.
  • Have mental health, family, social, or travel issues that could prevent following study rules or attending follow-up visits.
  • Have poor kidney function (eGFR below 50) or certain liver tests above the study limits: liver enzymes over 3 times normal or bilirubin over 2 times normal. The listing notes an exception for Gilbert’s syndrome.
  • Be unable or unwilling to stop folate, folic acid, or supplements containing folate 48 hours before getting the study drug.
  • Have had a serious harmful reaction to Cytalux before, if joining again for surgery on the other lung.
  • Turn 12 or 18 during study participation.
  • The listing puts a birth control rule for patients assigned male at birth under exclusions, but calls it an inclusion rule. It requires accepted birth control, including not having sex, from consent until 30 days after treatment. Ask the study team to clarify.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

IL