Development of a Fluorescent Visualization System for Non-visible Lung Cancer Nodules
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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 diagnoses 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 procedures remains mandatory.
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 favoring the use
of Cetuximab-IRDye800 would permit the use of a minimally invasive approach to a more
significant 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 costs, and an enhanced patient quality of life.
In addition, a result favoring 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 more accurate cancer
staging, and a tailored post-operative treatment. Finally, the investigators expect to
validate using Cetuximab-IRDye800 as an optimal tracker that can be easily applied
intraoperatively during minimally invasive surgical procedures.
Phase:
Phase 2
Details
Lead Sponsor:
University of Turin, Italy
Collaborator:
Azienda Ospedaliera Città della Salute e della Scienza di Torino