To date, lung resection and lymphadenectomy remains the best curative option in patients with early-stage non-small cell lung cancer. Moreover, cancer screening programs have led to a frequent diagnosis of indeterminate lung lesions, many of which require surgical biopsy for diagnosis and intervention. Additionally, pre-operative imaging assessment frequently underestimates lymph-node involvement. Finally, the increase in the utilization of minimally invasive procedure remains mandatory. MedDRA
Conditions
Interventions
Product Name: Cetuximab-800CW
Product Code: [N/A]
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: Cetuximab-800CW
Current Sponsor code: Manufacturing Licence
Sponsors
DIPARTIMENTO DI SCIENZE CHIRURGICHE - UNIVERSITà DEGLI STUDI DI TORINO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Clinical Stage I non-small cell lung cancer (according to 8th Edition of TNM Staging System) - Considered candidate to minimally invasive surgical resection after pre-operative assessment (i.e. Thorax and abdomen CT scans, PET, respiratory function test) [26] - age =18 years - age =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Previous systemic treatments (e.g. chemotherapy, immunotherapy) 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/mm - 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 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) - Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents - Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of our project is to verify if Cetuximab-IRDye800 could detect cancer nodules and lymph node metastases during minimally invasive thoracic surgery. A result in favor of the use of Cetuximab-IRDye800 would permit the use of a minimally invasive approach to a larger number of patients, which are presently operable only by a traditional “open” approach. Consequentially, it would lead to an improvement in surgical outcomes, a reduction of the costs, and an enhanced patients’ quality of life.;Secondary Objective: In addition, a result in favor of the use of Cetuximab-IRDye800 could consent to correctly remove mislead metastatic lymph-nodes (i.e. unexpected lymph-nodes metastasis) and neoplastic localization unidentified at pre-operative diagnostic assessments. It would lead to a more accurate cancer staging, a tailored post-operative treatment. Finally, we expect to validate the use of Cetuximab-IRDye800 as an optimal tracker that can be easily applied intraoperatively during minimally invasive surgical procedures.;Primary end point(s): The proportion of patients with detection of lung nodule during surgery by NIR camera, with respect to the pathology report.;Timepoint(s) of evaluation of this end point: Baseline assessment will be performed within 28 days before starting protocol treatment, including: Medical history, concomitant medications, physical examination, vital signs (arterial pressure, pulse rate), height and weight, Performance Status, laboratory exams (complete blood count, renal and liver function tests, serum pregnancy test (in women of childbearing potential)), CT scan of the thorax and abdomen with contrast medium; PET scan; Other exams for tumor assessment as clinically indicated. During surgery, the number and location of fluorescent location in lung and mediastinum will be registered. The time between the activation of the NIR camera and the visualization of the expected lung nodule will be also registered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The proportion of patients with detection of lymph nodal metastatic disease during surgery by NIR camera, with respect to the pathology report.; - The proportion of patients with detection of unexpected cancer localization during surgery by NIR camera, with respect to the pathology report.; - The proportion of patients with negative surgical margins, with respect to the pathology report.; - Time spawn the insertion of the NIR camera and the visualization of the nodule. Localization of the fluorescent compound the known nodule will be annotated.; - Toxicity will be recorded and classified according to the definitions of the NCI criteria “Common Terminology Criteria for Adverse Events (CTCAE)”, version 5.0.;Timepoint(s) of evaluation of this end point: During surgery, the number and location of fluorescent location in lung and mediastinum will be registered. The time between the activation of the NIR camera and the visualization of the expected lung nodule will be also registered. Patients should be monitored for toxicity and compliance with a clinical assessment after each cetuximab and cetuximab-IRDye administration, including assessment of side effects, physical examination, and laboratory exams.; During surgery, the number and location of fluorescent location in lung and mediastinum will be registered. The time between the activation of the NIR camera and the visualization of the expected lung nodule will be also registered. Patients should be monitored for toxicity and compliance with a clinical assessment after each cetuximab and c | — |
Countries
Italy
Contacts
Public ContactArea Servizi alla Ricerca
Dipartimento di Scienze Chirurgiche
Outcome results
None listed