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NCT06235125 · ClinicalTrials.gov registry record · Phase 1
Safety and Feasibility of Intraoperative Visualization With Cytalux in Children
A Phase 1 study of Osteosarcoma and Pediatrics, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06235125: Recruiting Phase 1 study of Osteosarcoma and Pediatrics, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
NCT06235125 is a Phase 1 study of Osteosarcoma and Pediatrics that is actively recruiting participants, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 10 participants, below the 302-participant average among 46 other Osteosarcoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06235125, a Phase 1 study of Osteosarcoma and Pediatrics, is actively recruiting participants, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Cytalux
Study Locations (1)
Illinois
- Ann & Robert H. Lurie Children's Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-04-08 |
| Est. Completion | 2026-01-20 |
| Phase | Phase 1 |
What NCT06235125 shows while recruiting
NCT06235125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 302-participant average among 46 other Osteosarcoma trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Osteosarcoma appearing as the primary indexed condition, and to 1 intervention - of which Cytalux is the first listed.
NCT06235125 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06235125 about?
NCT06235125 is a clinical study titled "Safety and Feasibility of Intraoperative Visualization With Cytalux in Children". 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.
What is the current status of trial NCT06235125?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2024-04-08. Estimated completion is 2026-01-20.
What conditions does trial NCT06235125 study?
This clinical trial studies the following conditions: Osteosarcoma, Pediatrics, Metastatic Sarcoma, Pulmonary Metastasis, Fluorescence.
What interventions are being tested in trial NCT06235125?
The interventions under investigation include: Cytalux (DRUG).
Who is sponsoring clinical trial NCT06235125?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06235125 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06235125's enrollment target sits among peer trials
10 44th of 46 the lowest of 46 other Osteosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteosarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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