Mayo Clinic
This clinical trial compares the addition of needle-based confocal laser endomicroscopy (nCLE) and fluorescein to endobronchial ultrasound-guided transbronchial needle aspiration (EBUS TBNA) with EBUS TBNA alone for the diagnosis of lung cancer in patients with peripheral pulmonary nodules. EBUS TBNA is a diagnostic procedure that can be used to sample lung tissue. nCLE is a novel high-resolution imaging technique that uses a laser light to create real-time microscopic images of tissues. It can be integrated into needles allowing real-time cancer detection during endoscopy. Fluorescein is an imaging agent that can be used to visualize tissue. Using nCLE and fluorescein in combination with EBUS TBNA may be more effective in diagnosing lung cancer than using EBUS TBNA alone.
Lung Carcinoma
Fluorescein
Image-Guided Needle Confocal Laser Endomicroscopy
Ultrasound-Guided Transbronchial Needle Aspiration
Not Applicable
PRIMARY OBJECTIVE: I. To compare the first-pass diagnostic yield of the sequential needle passes (rapid on-site evaluation [ROSE]) between the robotic-nCLE-TBNA arm and the robotic-guided arm in peripheral pulmonary nodule (PPNs). SECONDARY OBJECTIVES: I. To compare the per-patient diagnostic yield (cumulative pass diagnostic yield: cumulative number of passes until five cumulated passes) of robotic-nCLE-guided TBNA to that of robotic-guided TBNA in PPNs. II. To compare the proportion of patients with lung cancer treatment in the robotic-nCLE-guided TBNA arm to that of the robotic-guided TBNA arm in PPNs. III. To compare the proportion of patients with follow-up (video-assisted thoracoscopic surgery [VATS]) or transthoracic needle aspiration (TTNA) or TBNA procedures in the robotic-nCLE-guided TBNA arm to that of the robotic-guided TBNA arm in PPNs. IV. To compare the number of passes needed to obtain a final diagnosis of robotic-nCLE-guided TBNA to that of robotic-guided TBNA in PPNs. V. To assess the diagnostic performance (sensitivity, specificity, positive predictive value [PPV], negative predictive value [NPV], accuracy) of the sequential cumulative nCLE passes and the sequential cumulative ROSE passes using the final diagnosis as a reference. VI. To assess the feasibility by obtaining adequate confocal laser endomicroscopy (CLE) video footage in > 80% of the PPN punctures. VII. To assess the safety of nCLE imaging, as defined by: VIIa. The number and frequency of all adverse events (AE)/serious adverse events (SAE) from the start of the procedure until end of 12-month follow-up; VIIb. The number and frequency of nCLE procedure-related AE/SAE from the start of the procedure until end of 12-month follow-up. VIII. To assess the reproducibility of nCLE criteria to the reference standard. Three nCLE characteristics for the detection of malignancy were identified during Wijmans et al. study: VIIIa. Dark enlarged pleomorphic cells; VIIIb. Dark cell clusters consist of overlapping cell structures ('dark clumps') and; VIIIc. Continuous movement of the cells in one direction ('directional streaming'). IX. To create an nCLE image atlas for malignant characteristics in PPNs. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo robotic EBUS TBNA on study. ARM II: Patients undergo EBUS TBNA, nCLE, and receive fluorescein intravenously (IV) on study.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 118 participants |
| Masking : | Single |
| Masking Description : | Raters will be blinded to patient history and cytologic/pathologic diagnosis. |
| Primary Purpose : | Diagnostic |
| Official Title : | nCLE Guided Randomized Controlled Trial for Lung Cancer Diagnosis |
| Actual Study Start Date : | May 12, 2023 |
| Estimated Primary Completion Date : | May 23, 2025 |
| Estimated Study Completion Date : | May 23, 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Arm I (EBUS TBNA) Patients undergo robotic EBUS TBNA on study. |
Procedure: Ultrasound-Guided Transbronchial Needle Aspiration Other: Fluorescein |
|
Experimental: Arm II (EBUS TBNA, nCLE, fluorescein) Patients undergo EBUS TBNA, nCLE, and receive fluorescein IV on study. |
Device: Image-Guided Needle Confocal Laser Endomicroscopy Procedure: Ultrasound-Guided Transbronchial Needle Aspiration |
| Ages Eligible for Study: | 21 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Mayo Clinic in Florida
Jacksonville, florida, United States, 32224-9980
Not yet recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905