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

NCT06101394 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-01-25

No results posted yet for this study

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.

Conditions

  • Lung Cancer
  • Video-assisted Thoracic Surgery
  • EGFR
  • Cetuximab

Interventions

DRUG

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 & Collaborators

  • A.O.U. Città della Salute e della Scienza

    collaborator OTHER

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Enrico Ruffini, M.D. · Department of Surgical Science, University of Torino, Torino, Italy

  • Francesco Guerrera, M.D., Ph.D. · Department of Surgical Science, University of Torino, Torino, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06101394 on ClinicalTrials.gov