Development of a Fluorescent Visualization System for Non-visible Lung Cancer Nodules
RECOGNISE
Study Protocol for Near-infrared Molecular Imaging for Lung Cancer Detection and Treatment During Mini-invasive Surgery (Phase II Trial) - (the RECOGNISE Study)
1 other identifier
interventional
25
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lung-cancer
Started Jan 2024
Shorter than P25 for phase_2 lung-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 26, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJanuary 25, 2024
January 1, 2024
1.5 years
March 27, 2023
January 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Nodule Detection
The proportion of patients with detection of lung nodules during surgery by NIR camera, with respect to the pathology report.
The detection of lung nodules' NIR emission was registered in the first 5 minutes of the NIR camera activation during surgery.
Secondary Outcomes (5)
Lymph node detection
The lymph-nodal NIR emission was revealed and registered during surgery at the same time as the lymph-nodal dissection was performed.
Unexpected cancer localization detection
Unexpected localization of NIR emission was researched and registered at the end of standard surgical procedure with systematic research of 10 minutes.
Negative surgical margins, with respect to the pathology report.
The nature of the surgical margin (e.g., if neoplastic or not) will be registered during pathological examination of the specimen, up to 15 days after surgical procedure
Detection speed
The detection time of NIR emission was registered in the first 5 minutes of activation of the NIR camera, at the beginning of surgical procedure, after all the pleurotomy have been performed.
Toxicity Incidence
The morbidity or toxicity will be assessed during and after drug infusion (Day0), during and after a hospital stay (Day1 to Day13), and during the control visits (in averange until the first year after drug infusion).
Study Arms (1)
cetuximab-IRDye800
EXPERIMENTALInfusion 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous systemic treatments 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/mm³
- Leukocyte count \< 3000/mm³
- Absolute neutrophil count \< 1500/mm³
- 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 or 5 half-life 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)
- Hypersensitivity to Cetuximab-IRDye800, Cetuximab, or any of the excipients.
- Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Torino, TO, 10126, Italy
S.C. Chirurgia Toracica U, Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Related Publications (1)
Beffa ED, Lyberis P, Rosboch GL, Arezzo A, Lococo F, Carena L, Sciorsci E, Monica V, Lausi PO, Dusi V, Busardo FP, Buffa E, Stefania R, Ciccone G, Monagheddu C, Capello BM, Vancheri R, Garrone P, Gabbarini F, Cattel F, Ruffini E, Guerrera F. Study protocol for Near-infrared molecular imaging for lung cancer detection and treatment during mini-invasive surgery (phase II Trial) - (the RECOGNISE study). BMC Cancer. 2024 Sep 2;24(1):1078. doi: 10.1186/s12885-024-12859-6.
PMID: 39218855DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Enrico Ruffini, M.D.
Department of Surgical Science, University of Torino, Torino, Italy
- PRINCIPAL INVESTIGATOR
Francesco Guerrera, M.D., Ph.D.
Department of Surgical Science, University of Torino, Torino, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2023
First Posted
October 26, 2023
Study Start
January 1, 2024
Primary Completion
July 1, 2025
Study Completion
December 1, 2025
Last Updated
January 25, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share