Safety and Feasibility of Intraoperative Visualization With Cytalux in Children
- Conditions
- OsteosarcomaPediatricsPulmonary MetastasisFluorescenceMetastatic Sarcoma
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria:<br><br> 1. Patients 6-17 years of age at the time of study enrollment<br><br> 2. Willingness of research participant or legal guardian/representative to give written<br> informed consent<br><br> 3. Willingness of patients (subjects) age 12-17 to provide written adolescent assent<br><br> 4. Patient weight greater than or equal to 20 kg<br><br> 5. Histologically confirmed diagnosis of osteosarcoma, synovial sarcoma,<br> hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor or other<br> non-rhabdomyosarcoma soft tissue sarcoma<br><br> 6. Imaging findings highly suspicious for pulmonary metastatic disease based on CT,<br> PET-CT or other imaging and warranting pulmonary surgery based on the judgment of<br> the treating team. At least one nodule =4mm measured by preoperative imaging.<br><br> 7. Female (assigned female at birth) participant is not pregnant and agrees to an<br> acceptable form of contraception from the time of consent through 30 days after<br> study intervention. Confirmed abstinence is an acceptable form of contraception.<br><br> 8. Female (assigned female at birth) participant must agree to not donate ova from time<br> of consent until 30 days after study intervention<br><br> 9. Male (assigned male at birth) participant must agree to not donate sperm from time<br> of consent until 30 days after study intervention.<br><br>Exclusion Criteria:<br><br> 1. Any medical condition that in the opinion of the investigators could potentially<br> jeopardize the safety of the subject<br><br> 2. History of anaphylactic reactions to products containing indocyanine green for near<br> infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will<br> also be excluded.<br><br> 3. History of allergy to any of the components of CYTALUX™ (PAFOLACIANINE) INJECTION<br><br> 4. Presence of any psychological, familial, sociological condition or geographical<br> challenges potentially hampering compliance with the study protocol or follow-up<br> schedule<br><br> 5. Impaired renal function defined as eGFR< 50 mL/min/1.73m2<br><br> 6. Impaired liver function defined as values > 3x the upper limit of normal (ULN) for<br> alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline<br> phosphatase (ALP), or >2x ULN for total bilirubin except in subjects with Gilbert's<br> syndrome.<br><br> 7. Patient unable or unwilling to discontinue folate, folic acid, or folate-containing<br> supplements 48 hours before study drug administration<br><br> 8. History of drug-related serious adverse event with prior Cytalux administration will<br> be an exclusion for re-enrollment for contralateral surgery (see section 5.7).<br><br> 9. Participants will be excluded if their 12th or 18th birthday would occur during<br> study participation<br><br> 10. Male sex at birth and commitment to acceptable form of contraception from time of<br> consent through 30 days after study intervention with confirmed abstinence as an<br> acceptable form of contraception as an inclusion criterion.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Detection of occult metastatic lesion(s) with Near-infrared (NIR) imaging after pafolacianine injection;Number of patients with treatment-emergent adverse events (TEAEs)