Needle-Based Confocal Laser Endomicroscopy for Diagnosis of Lung Cancer in Patients With Peripheral Pulmonary Nodules

Lung Carcinoma Clinical Trial

Official title:

nCLE Guided Randomized Controlled Trial for Lung Cancer Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556525
• Other study ID #: MKT_2021_lung_01
• Secondary ID: NCI-2022-0766021
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: May 23, 2025

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: May 23, 2025
• Est. primary completion date: May 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• >= 21 years of age

• Suspected PPN

• Nodule size in computed tomography (CT) between 8 mm and 30 mm (largest dimension)

• Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document

Exclusion Criteria:

• Inability or non-willingness to provide informed consent

• Failure to comply with the study protocol

• Patients with known allergy for fluorescein or risk factors for an allergic reaction

• Use of beta-blocker within 24 hours before the start of the bronchoscopic procedure

• Possibly pregnant, pregnant or breastfeeding women

• Patients with hemodynamic instability

• Patients with refractory hypoxemia

• Patients with a therapeutic anticoagulant that cannot be held for an appropriate interval before the procedure

• Patients who are unable to tolerate general anesthesia according to the anesthesiologist

• Patient undergoing chemotherapy

• INTRA-OPERATIVE EXCLUSION/STOPPING CRITERIA:

• The lesions are unable to be localized/confirmed by bronchoscopy

• The procedure will be terminated if the patient develops a significant procedural complication as determined by the treating physician

• The procedure will be terminated if the patient develops hemodynamic instability as determined by the treating physician

Related Conditions & MeSH terms

• Lung Carcinoma
• Lung Neoplasms

Intervention

Other:
• Fluorescein
Given IV

Device:
• Image-Guided Needle Confocal Laser Endomicroscopy
Undergo nCLE

Procedure:
• Ultrasound-Guided Transbronchial Needle Aspiration
Undergo EBUS TBNA

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical impact of needle-based confocal laser endomicroscopy (nCLE)	Assessed by determining the proportion of patients with a correct change in definitive diagnosis and the associated change in management plan with nCLE. Overall diagnostic and therapeutic management proportion differences in the two arms will be compared using a chi-square test. Differences between the two arms regarding the specific diagnostic and therapeutic management categories will be compared using McNemar's test.	Up to 2 years
Primary	First-pass diagnostic yield	Calculated as the proportion of patients for which first-pass transbronchial needle aspiration during bronchoscopic procedure yielded a definitive diagnosis out of the total number of patients that have received a diagnostic procedure.	Up to 2 years
Secondary	Per-patient diagnostic yield	Calculated as the proportion of patients in whom the bronchoscopic procedure yielded a definitive diagnosis out of the total number of patients that have received a diagnostic procedure. Per patient diagnostic yield of each bronchoscopic procedure will be calculated, and the accuracy of each technique using the final/definitive diagnosis as the reference. The diagnostic yield and accuracy for each method will be compared.	Up to 2 years

External Links

•   Mayo Clinic Clinical Trials