Cytalux for Detecting Lung Metastasis in Children with Cancer
This study is looking at how well a special dye called Cytalux (pafolacianine) helps surgeons find cancer that has spread to the lungs (pulmonary metastasis) in children aged 6 to 17. These children have osteosarcoma or other metastatic sarcomas and are having surgery to remove these lung tumors. Cytalux works by targeting certain features on cancer cells, like the folate receptor, to make them glow during surgery. The main goals are to see how accurately Cytalux helps identify these metastatic nodules and how often it incorrectly highlights non-cancerous areas. The study plans to enroll 10 participants.
- Study design
- This is an interventional study with a planned enrollment of 10 participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at 1 day after the injection, indicating a short follow-up period for these specific measurements.
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Safety and Feasibility of Intraoperative Visualization With Cytalux in Children
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Timothy Lautz, MD · PRINCIPAL_INVESTIGATOR · Ann & Robert H Lurie Children's Hospital of Chicago
Who to contact
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What this trial measures
- Sensitivity of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification1 day
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.
- False-Positive Rate of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification1 day
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.