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All participants will receive Cytalux and undergo near infrared imaging.

Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

Cytalux

Timothy Lautz, MD

Seth Goldstein, MD

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.

Pulmonary metastasectomy, or surgery to remove cancer which has spread to the lungs, plays a key role in the treatment of children with metastatic solid tumors. Fluorescence-guided surgery (FGS) has been shown to be a promising technique to highlight cancer cells and enable real-time surgical guidance (Stummer 2006, Hernot 2019, Goldstein 2021). Current techniques for fluorescence-guided surgery rely on indocyanine green (ICG), a non-specific fluorescent molecular agent which tends to accumulate in cancer cells because of increased angiogenesis and decreased lymphatic clearance. Molecular agents targeted to tumor-specific receptors offer the hope of increased sensitivity and specificity for detecting even very small metastatic nodules, and thus enhancing surgical clearance of disease.

Many of the tumors which metastasize to the lung are known to express the folate receptor and may therefore benefit from utilizing the tumor imaging agent CYTALUX (pafolacianine). CYTALUX (Pafolacianine) as a diagnostic tool during cancer resection has already been investigated in adults (approved NDA 214907), and no age-specific differences are expected in the pediatric population. Findings from the ELUCIDATE trial in adults demonstrated that intraoperative molecular imaging with CYTALUX (pafolacianine) improves surgical outcomes by identifying occult tumors and close surgical margins and it therefore gained FDA approval for adults with cancer in the lung (both primary and metastatic) as an adjunct with near infrared (NIR) imaging for detection of disease during surgery. We anticipate that this agent will have similar safety and efficacy in children and to similarly demonstrate applicable for all types of metastatic tumors.

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.

In the proposed study, subjects and their parents or guardians will give informed consent prior to commencement of any study procedures. Subjects will be dosed with 0.025 mg/kg CYTALUX (pafolacianine) injection intravenously from 4 hours to up to 24 hours prior to surgery. Subjects will be considered evaluable if they are exposed to study drug and/or NIR fluorescent light imaging. During surgery, all subjects will first undergo evaluation by normal surgical techniques (white light, palpation, and/or other localization techniques) and all suspicious nodules and lesions identified under standard surgical approach will be recorded as such. Following standard surgical assessment, subjects will undergo assessment with NIR fluorescent light imaging prior to and after resection.

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

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.

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.

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

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

On Target Laboratories, LLC

Ann & Robert H Lurie Children's Hospital of Chicago

Director of Pediatric Surgical Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Feasibility of Intraoperative Visualization With Cytalux in Children	NCT06235125	Osteosarcoma Pulmonary Metas... Fluorescence Metastatic Sarc... Pediatrics	Cytalux	6 Years - 17 Years	Ann & Robert H Lurie Children's Hospital of Chicago
Safety and Feasibility of Intraoperative Visualization With Cytalux in Children	NCT06235125	Osteosarcoma Pulmonary Metas... Fluorescence Metastatic Sarc... Pediatrics	Cytalux	6 Years - 17 Years	Ann & Robert H Lurie Children's Hospital of Chicago

Spots Global Cancer Trial Database for cytalux

Every month we try and update this database with for cytalux cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cytalux

Every month we try and update this database with for cytalux cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cytalux cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.