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Virus Therapy
Cytalux for Lung Metastasis in Children (Cytalux Trial)
Phase 1
Recruiting
Led By Timothy Lautz, MD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients aged 6-17 at the time of study enrollment
Patient weight greater than or equal to 20 kg
Must not have
History of allergy to any of the components of CYTALUX™ (PAFOLACIANINE) INJECTION
Participants will be excluded if their 12th or 18th birthday would occur during study participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking for children and teenagers between the ages of 6 and 17 who have been diagnosed with cancer through a biopsy and have suspicious findings of cancer spreading to the lungs. They will undergo
Who is the study for?
This trial is for children aged 6-17 with certain types of cancer like osteosarcoma, who are scheduled for lung surgery to remove suspected metastases. They must weigh at least 20 kg and agree to use contraception or practice abstinence if applicable. Children under 12 need guardian consent, while those 12-17 must also give assent.
What is being tested?
The trial is testing the safety and feasibility of using Cytalux during surgery in pediatric patients. Cytalux helps surgeons see cancerous cells better to potentially improve the removal process during pulmonary metastasectomy.
What are the potential side effects?
Specific side effects of Cytalux are not detailed here, but generally, fluorescence imaging agents can cause allergic reactions, tissue irritation, or interfere with other diagnostic tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 and 17 years old.
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I weigh at least 20 kg.
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I have been diagnosed with a specific type of sarcoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to ingredients in CYTALUX™.
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I will not turn 12 or 18 years old during the study.
Select...
My kidney function is reduced with an eGFR below 50.
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I have never had a severe reaction to Cytalux.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
False-Positive Rate of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification
Sensitivity of Near-infrared (NIR) imaging after pafolacianine injection for metastatic nodule identification
Secondary study objectives
Detection of occult metastatic lesion(s) with Near-infrared (NIR) imaging after pafolacianine injection
Number of patients with treatment-emergent adverse events (TEAEs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cytalux with Near Infrared ImagingExperimental Treatment1 Intervention
All participants will receive Cytalux and undergo near infrared imaging.
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Who is running the clinical trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
264 Previous Clinical Trials
5,182,664 Total Patients Enrolled
On Target Laboratories, LLCIndustry Sponsor
6 Previous Clinical Trials
445 Total Patients Enrolled
Timothy Lautz, MDPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago
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