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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NCT06235125

Safety and Feasibility of Intraoperative Visualization With Cytalux in Children

Recruiting
PHASE1Ages 6–17InterventionalDiagnostic
Ann & Robert H Lurie Children's Hospital of Chicago
~10 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Cytalux

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification
Measured over 1 day
+1 more outcome measured
Osteosarcoma
Pulmonary Metastasis
Fluorescence
Metastatic Sarcoma
Pediatrics
1 sites across 1 states
Illinois1
  • Timothy Lautz, MD · PRINCIPAL_INVESTIGATOR · Ann & Robert H Lurie Children's Hospital of Chicago

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  • 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.