Clinical trial · Interventional
Minimally Invasive, Diagnosis and Staging of Lung Cancer
Minimally Invasive, Trans-Luminal Diagnosis and Staging of Lung Cancer: A Prospective Head-to-Head Comparison With Traditional Gold Standard Diagnostic Techniques
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The gold standard techniques to assess the extent of disease and decide on therapy for patients with lung cancer consists of cervical mediastinoscopy, which is a surgical procedure which entails an incision in the neck and the removal of lymph nodes from around the airway. Endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) are new, non-surgical techniques that have been available for the past several years and are proving invaluable in lung cancer evaluation. These techniques are minimally invasive and can be performed without surgery. To date, there have been no head-to-head studies on the same group of patients using both the old and new techniques. The study will consist of a study which compares traditional staging techniques in lung cancer patients to new, less invasive techniques. The significance of the proposed project is tremendous. If the new strategies prove to be equivalent (or superior) to traditional techniques, these techniques will be considered the new gold-standard tests. This will change the way lung cancer is evaluated. An equivalent or superior result will also significantly impact on patient care, cost and morbidity due to the speed, convenience and lack of operating room requirement as well as the lack of general anesthesia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical Mediastinoscopy | Procedure | — | UNRESOLVED |
| Endobronchial Ultrasound (EBUS) | Procedure | — | UNRESOLVED |
| Endoscopic Ultrasound (EUS) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary outcome measure will be the accuracy of the combination of minimally invasive diagnostic tests to correctly diagnose the presence or absence of mediastinal lymph node metastases compared to mediastinoscopy.
- timeFrame
- 3-6 months
- description
- Define and compare the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio and accuriacies between traditional and minimally invasive mediastinal diagnostic and staging techniques for lung cancer.
Secondary outcomes (4)
- measure
- The safety of all diagnostic techniques will be evaluated and compared between techniques.
- timeFrame
- 3-6 months
- description
- Compare morbidity, convenience, cost and efficiencies between traditional and minimally invasive diagnostic strategies.
- measure
- Procedure-related morbidity
- timeFrame
- 3-6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Lung lesion with mediastinal lymphadenopathy\* and/or positive PET scan in the mediastinum * Lung lesion (\>1cm) without mediastinal lymphadenopathy\* or positive PET scan in the mediastinum Exclusion Criteria: * Age \< 18 years old * CT or PET positivity in an extra-thoracic site (adrenal, liver, brain, bone…) * Indeterminate pulmonary nodule less than 1cm in diameter without mediastinal lymphadenopathy\* on CT and a negative PET scan * History of previous mediastinoscopy * Biopsy proven positive mediastinal LN(s) * Inability to consent for the study * Cervical or thoracic anatomy precluding mediastinoscopy * Inability to tolerate general anesthesia * Pre-operative plan for carinal resection or carinal pneumonectomy (CM contraindicated prior to operative procedure due to additional difficulty secondary to scarring at time of resection) * Active pulmonary infection (bronchitis, pneumonia) * Active cutaneous infection overlying proposed surgical site(s) Lymphadenopathy will be defined as short axis LN diameter of \>10 mm on CT scan
References
Publications (1)
- DERIVEDLiberman M, Sampalis J, Duranceau A, Thiffault V, Hadjeres R, Ferraro P. Endosonographic mediastinal lymph node staging of lung cancer. Chest. 2014 Aug;146(2):389-397. doi: 10.1378/chest.13-2349. PMID 24603902