Status:
RECRUITING
Development of a Fluorescent Visualization System for Non-visible Lung Cancer Nodules
Lead Sponsor:
University of Turin, Italy
Collaborating Sponsors:
A.O.U. Città della Salute e della Scienza
Conditions:
Lung Cancer
Video-assisted Thoracic Surgery
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
To date, lung resection and lymphadenectomy remain the best curative option in patients with early-stage non-small cell lung cancer. Moreover, cancer screening programs have led to a frequent diagnose...
Detailed Description
Lung cancer is the leading cause of cancer deaths in the European Union (EU) (267,000 deaths/year) and the fourth most common cancer (321,000 new cases/year). To date, radical surgery remains the best...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Clinical Stage I non-small cell lung cancer
- \- Considered candidate to minimally invasive surgical resection after pre-operative assessment
- Adequate organ function
- Performance status (ECOG) ≤2
- 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
- Written informed consent
- Exclusion criteria:
- Previous systemic treatments for lung cancer
- Previous radiotherapy on lung or mediastinum
- \- Concomitant disorders that compromise the ability to adhere to the procedures of the Protocol
- Hemoglobin \< 9 gm/dL
- Platelet count \< 100,000/mm³
- Leukocyte count \< 3000/mm³
- Absolute neutrophil count \< 1500/mm³
- Magnesium, potassium, and calcium \< the lower limit of normal per institution normal lab values
- Thyroid-stimulating hormone (TSH) \> 13 micro international units/mL
- Received an investigational drug within 30 days or 5 half-life prior to the first dose of cetuximab IRDye800
- Within 6 months prior to enrollment, myocardial infarction; cerebrovascular accident; uncontrolled congestive heart failure; significant liver disease; or unstable angina
- History of infusion reactions to cetuximab or other monoclonal antibody therapies
- Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
- Hypersensitivity to Cetuximab-IRDye800, Cetuximab, or any of the excipients.
- Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- Pregnancy, assessed by a pregnancy serum test (βhCG), or breastfeeding
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06101394
Start Date
January 1 2024
End Date
December 1 2025
Last Update
January 25 2024
Active Locations (2)
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1
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Torino, TO, Italy, 10126
2
S.C. Chirurgia Toracica U, Città della Salute e della Scienza di Torino
Torino, Italy, 10126