Clinical trial NCT05556525: Needle-Based Confocal Laser Endomicroscopy for Diagnosis of Lung Cancer in Patients With Peripheral Pulmonary Nodules
Official title: nCLE Guided Randomized Controlled Trial for Lung Cancer Diagnosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: First-pass diagnostic yield
timeFrame: Up to 2 years
Secondary outcomes:
measure: Per-patient diagnostic yield
timeFrame: Up to 2 years
Other outcomes:
measure: Clinical impact of needle-based confocal laser endomicroscopy (nCLE)
timeFrame: Up to 2 years
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sebastian Fernandez-Bussy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: