Safety and Feasibility of Intraoperative Visualization With Cytalux in Children
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6-17
SponsorAnn & Robert H Lurie Children's Hospital of Chicago
About this trial
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.
Eligibility criteria
Qualifiers
Patients 6-17 years of age at the time of study enrollment
Willingness of research participant or legal guardian/representative to give written informed consent
Willingness of patients (subjects) age 12-17 to provide written adolescent assent
Patient weight greater than or equal to 20 kg
Disqualifiers
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will also be excluded.
History of allergy to any of the components of CYTALUX™ (PAFOLACIANINE) INJECTION
Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
Trial design
Treatments tested in this trial
- Cytalux
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
On Target Laboratories, LLC
Collaborator
Source ClinicalTrials.gov