Safety and Feasibility of Intraoperative Visualization With Cytalux in Children

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study ID
NCT06235125
Phase
PHASE1
Status
Recruiting
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Conditions

  • Fluorescence
  • Metastatic Sarcoma
  • Osteosarcoma
  • Pediatrics
  • Pulmonary Metastasis

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 8, 2024
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cytalux with Near Infrared Imaging
    All participants will receive Cytalux and undergo near infrared imaging.

Primary Outcome Measure

Sensitivity of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's HospitalChicagoIllinois60611
Timothy Lautz, MD
[email protected]
312-227-4210
Seth D Goldstein, MD
[email protected]
312-227-4210

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By research site
Ann & Robert H. Lurie Children's Hospital· Chicago, IL

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