Safety and Feasibility of Intraoperative Visualization With Cytalux in Children

NCT06235125 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-08-22

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Cytalux

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

Sponsors & Collaborators

  • On Target Laboratories, LLC

    collaborator INDUSTRY
  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

  • Timothy Lautz, MD · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2026-01-20
Completion
2026-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06235125 on ClinicalTrials.gov