Study Protocol for Near-infrared Molecular Imaging for Lung Cancer Detection and Treatment During Mini-invasive Surgery (Phase II Trial) - (the RECOGNISE Study)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
NOT_YET_RECRUITING
Torino
S.C. Chirurgia Toracica U, Città della Salute e della Scienza di Torino
RECRUITING
Torino
Contact Information
Primary
Francesco Guerrera, M.D. Ph.D.
francesco.guerrera@unito.it
+39 011 633 6777
Backup
Luca Cavallo
luca.cavallo@unito.it
+39 011 6708362
Time Frame
Start Date: 2024-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 25
Treatments
Experimental: cetuximab-IRDye800
Infusion of the study drug will be performed 2-5 days before the surgery: the patients will receive 100 mg of cetuximab intravenously over 30 minutes and a dose 50 mg of cetuximab IRDye800 over 30 minutes to 1 hour.
Sponsors
Leads: University of Turin, Italy
Collaborators: A.O.U. Città della Salute e della Scienza

This content was sourced from clinicaltrials.gov