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Tests treatment safety and results for Osteosarcoma
Official title Safety and Feasibility of Intraoperative Visualization With Cytalux in Children
ClinicalTrials.gov ID: NCT06235125
What this study is testing
What is Cytalux?
Cytalux is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for osteosarcoma.
Also referred to as Pafolacianine injection, OTL38 injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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 (people) 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...
You likely can't join if
- 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. people with a medical history of 'idiopathic...
- 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...
- 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...
See the full eligibility criteria
- 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 (people) 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...
- 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...
- 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.
- 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. people 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
- 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...
- 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).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.