Actively Recruiting
Safety and Feasibility of Intraoperative Visualization With Cytalux in Children
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2024-08-22
10
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
Sponsors
A
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
O
On Target Laboratories, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety and Feasibility of Intraoperative Visualization With Cytalux in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 6-17 years of age at the time of study enrollment
- Willingness of participant or legal guardian to give written informed consent
- Willingness of patients aged 12-17 to provide written adolescent assent
- Patient weight greater than or equal to 20 kg
- Histologically confirmed diagnosis of osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor, or other non-rhabdomyosarcoma soft tissue sarcoma
- Imaging findings highly suspicious for pulmonary metastatic disease with at least one nodule 4 mm or larger that warrants pulmonary surgery
- Female participants (assigned female at birth) are not pregnant and agree to acceptable contraception or confirmed abstinence from consent through 30 days after study intervention
- Female participants agree not to donate ova from consent until 30 days after study intervention
- Male participants (assigned male at birth) agree not to donate sperm from consent until 30 days after study intervention
You will not qualify if you...
- Any medical condition that could jeopardize the safety of the participant according to investigators
- History of anaphylactic reactions to indocyanine green or a history of idiopathic anaphylaxis
- Allergy to any components of Cytalux (pafolacianine) injection
- Psychological, familial, sociological, or geographical conditions that could interfere with study compliance or follow-up
- Impaired kidney function with eGFR less than 50 mL/min/1.73m2
- Impaired liver function with liver enzymes greater than 3 times the upper limit of normal or bilirubin greater than 2 times the upper limit except for Gilbert's syndrome
- Unable or unwilling to stop folate, folic acid, or folate-containing supplements 48 hours before study drug administration
- History of serious adverse event related to prior Cytalux administration excluding re-enrollment for contralateral surgery
- Participants whose 12th or 18th birthday will occur during study participation
- Male participants must commit to acceptable contraception or confirmed abstinence from consent through 30 days after study intervention as an inclusion criterion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
T
Timothy Lautz, MD
CONTACT
S
Seth Goldstein, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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