Fluorescent system to detect lung cancer nodules during surgery
Study Protocol for Near-infrared Molecular Imaging for Lung Cancer Detection and Treatment During Mini-invasive Surgery (Phase II Trial) - (the RECOGNISE Study)
This study is testing a special dye to see if it can help doctors find lung cancer nodules during surgery for patients with early-stage non-small cell lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Turin, Italy Academic / other |
| Drugs / interventions | cetuximab |
| Locations | 2 sites (Torino, TO and 1 other locations) |
| Trial ID | NCT06101394 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of Cetuximab-IRDye800 in detecting cancer nodules and lymph node metastases during minimally invasive thoracic surgery for patients with early-stage non-small cell lung cancer. The study will involve patients who are candidates for surgical resection after pre-operative assessment, focusing on improving surgical outcomes and reducing costs. By utilizing this fluorescent visualization system, the goal is to increase the number of patients who can undergo minimally invasive procedures rather than traditional open surgery.
Who should consider this trial
Good fit: Ideal candidates include individuals with clinical Stage I non-small cell lung cancer who are suitable for minimally invasive surgical resection.
Not a fit: Patients with previous systemic treatments for lung cancer or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance surgical outcomes and quality of life for lung cancer patients.
How similar studies have performed: While the use of fluorescent agents in surgery is an emerging field, this specific application of Cetuximab-IRDye800 for lung cancer detection is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Clinical Stage I non-small cell lung cancer 2. - Considered candidate to minimally invasive surgical resection after pre-operative assessment 3. Adequate organ function 4. Performance status (ECOG) ≤2 5. 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 6. Written informed consent Exclusion criteria: 1. Previous systemic treatments for lung cancer 2. Previous radiotherapy on lung or mediastinum 3. - Concomitant disorders that compromise the ability to adhere to the procedures of the Protocol 4. Hemoglobin \< 9 gm/dL 5. Platelet count \< 100,000/mm³ 6. Leukocyte count \< 3000/mm³ 7. Absolute neutrophil count \< 1500/mm³ 8. Magnesium, potassium, and calcium \< the lower limit of normal per institution normal lab values 9. Thyroid-stimulating hormone (TSH) \> 13 micro international units/mL 10. Received an investigational drug within 30 days or 5 half-life prior to the first dose of cetuximab IRDye800 11. Within 6 months prior to enrollment, myocardial infarction; cerebrovascular accident; uncontrolled congestive heart failure; significant liver disease; or unstable angina 12. History of infusion reactions to cetuximab or other monoclonal antibody therapies 13. Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females) 14. Hypersensitivity to Cetuximab-IRDye800, Cetuximab, or any of the excipients. 15. Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents 16. Pregnancy, assessed by a pregnancy serum test (βhCG), or breastfeeding
Where this trial is running
Torino, TO and 1 other locations
- Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino — Torino, To, Italy (Not_yet_recruiting)
- S.C. Chirurgia Toracica U, Città della Salute e della Scienza di Torino — Torino, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco Guerrera, M.D., Ph.D. — Department of Surgical Science, University of Torino, Torino, Italy
- Study coordinator: Francesco Guerrera, M.D. Ph.D.
- Email: francesco.guerrera@unito.it
- Phone: +39 011 633 6777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.