Development of a Fluorescent Visualization System for Non-visible Lung Cancer Nodules

Launched by UNIVERSITY OF TURIN, ITALY · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new method to help doctors find small lung cancer nodules and affected lymph nodes during surgery. The researchers are testing a special dye called Cetuximab-IRDye800, which is hoped to make these cancerous areas visible during minimally invasive surgeries. This approach could allow more patients to have less invasive procedures instead of traditional open surgeries, leading to better recovery, lower costs, and improved quality of life.

To participate in this study, you should be an adult aged 65 to 74 years with early-stage non-small cell lung cancer who is eligible for minimally invasive surgery. You will need to meet certain health criteria, such as having good organ function and being able to follow the study requirements. If you join the trial, you can expect to receive the study medication and be monitored closely to see how well it works in helping doctors locate any hidden cancer during surgery. It’s important to know that some people may not qualify based on their medical history or current health conditions, but the goal is to improve cancer treatment for many patients.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Clinical Stage I non-small cell lung cancer
• • 2. - Considered candidate to minimally invasive surgical resection after pre-operative assessment
• • 3. Adequate organ function
• • 4. Performance status (ECOG) ≤2
• • 5. Potentially fertile female subjects must agree to use highly effective contraception throughout the - study and for three months after the last dose of the study medication
• • 6. Written informed consent
• Exclusion criteria:
• • 1. Previous systemic treatments for lung cancer
• • 2. Previous radiotherapy on lung or mediastinum
• • 3. - Concomitant disorders that compromise the ability to adhere to the procedures of the Protocol
• • 4. Hemoglobin \< 9 gm/dL
• • 5. Platelet count \< 100,000/mm³
• • 6. Leukocyte count \< 3000/mm³
• • 7. Absolute neutrophil count \< 1500/mm³
• • 8. Magnesium, potassium, and calcium \< the lower limit of normal per institution normal lab values
• • 9. Thyroid-stimulating hormone (TSH) \> 13 micro international units/mL
• • 10. Received an investigational drug within 30 days or 5 half-life prior to the first dose of cetuximab IRDye800
• • 11. Within 6 months prior to enrollment, myocardial infarction; cerebrovascular accident; uncontrolled congestive heart failure; significant liver disease; or unstable angina
• • 12. History of infusion reactions to cetuximab or other monoclonal antibody therapies
• • 13. Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
• • 14. Hypersensitivity to Cetuximab-IRDye800, Cetuximab, or any of the excipients.
• • 15. Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
• • 16. Pregnancy, assessed by a pregnancy serum test (βhCG), or breastfeeding