Osteosarcoma Clinical Trial
— CytaluxOfficial title:
A Pilot Study of Near-Infrared Imaging Using the Novel Imaging Agent Cytalux for Adolescent Patients With Metastatic Osteosarcoma Undergoing Pulmonary Metastasectomy
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 | Not yet recruiting |
Enrollment | 10 |
Est. completion date | January 20, 2026 |
Est. primary completion date | January 20, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ann & Robert H Lurie Children's Hospital of Chicago | On Target Laboratories, LLC |
Sarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Dec;166(6):e468-e478. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification | In children and adolescents with histologically-confirmed cancer undergoing pulmonary surgery for suspected metastases, each excised pulmonary lesion will be classified by the surgeon as positive or negative on NIR imaging after administration CYTALUX™ (PAFOLACIANINE) and then subjected to routine histologic examination. Sensitivity will be assessed as the fraction of histologically-confirmed metastatic nodules which demonstrated positive NIR fluorescence. | 1 day | |
Primary | False-Positive Rate of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification | In children and adolescents with histologically-confirmed cancer undergoing pulmonary surgery for suspected metastases, each excised pulmonary lesion will be classified by the surgeon as positive or negative on NIR imaging after administration CYTALUX™ (PAFOLACIANINE) and then subjected to routine histologic examination. The false positive rate will be assessed as the fraction of NIR-positive nodules that have no viable malignancy on histologic examination. | 1 day | |
Secondary | Detection of occult metastatic lesion(s) with Near-infrared (NIR) imaging after pafolacianine injection | The proportion of subjects with one or more NIR-positive lesion(s), not detected under normal light and/or palpation, and subsequently determined on histologic evaluation to contain viable metastatic tumor | 1 day | |
Secondary | Number of patients with treatment-emergent adverse events (TEAEs) | Adverse events (AEs) will be coded using MedDRA. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as an AE observed after administration of the study intervention and up to the follow-up period. The number of TEAEs will be collected to asses the safety and tolerability of single intravenous infusions/injection of CYTALUX™ (PAFOLACIANINE) INJECTION in children and adolescents | 30 days |
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