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Not yet recruiting NCT06910046

GGO-dominant PPLs Diagnosis Using CLE and ssRAB-guided Cryobiopsy

No phase Interventional Lung Ground-Glass Opacity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CLE and ssRAB-guided cryobiopsy.
Who it may be relevant to
Registry conditions: Lung Ground-Glass Opacity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Ground-glass Opacity-dominant Peripheral Pulmonary Lesions Diagnosis Using Confocal Laser Endomicroscopy and Shape-sensing Robotic-assisted Bronchoscopy Guided Cryobiopsy: GLASS-CLEAR Study

Overview

The purpose of the study is to evaluate the diagnostic performance and safety of cryobiopsy for ground-glass opacity (GGO)-dominant peripheral pulmonary lesions (PPLs) under the guidance of shape-sensing robotic-assisted bronchoscopy (ssRAB) combined with confocal laser endomicroscopy (CLE). Additionally, the study aims to establish CLE interpretation criteria for GGO-dominant PPLs based on histopathological characteristics and validate the proposed criteria.

Detailed description

This is a single-arm, single-center, and prospective study. Approximately 119 patients with GGO-dominant PPLs will be enrolled to undergo CLE and ssRAB-guided cryobiopsy for the diagnosis of lesions. During the procedure, CLE will be used to examine the lesion. The primary endpoint is the diagnostic yield of the procedure. The secondary endpoints include the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the procedure, CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions, and the complication rate.

Interventions

  • Diagnostic test CLE and ssRAB-guided cryobiopsy
    All procedures are performed under general anesthesia with endotracheal intubation and mechanical ventilation. A conventional flexible bronchoscope is used to examine the subject's airway and clear the secretion. After the registration procedure is completed, the catheter of the ssRAB system is navigated to the target lesion. Cone beam computed tomography (CBCT) is used to confirm whether the target lesion has been reached. After that, an appropriate CLE probe is inserted. Right before CLE imagi

Primary outcome measures

  • Diagnostic yield [Time frame: 1 year]
Secondary outcome measures (5)
  • Diagnostic accuracy [Time frame: 1 year]
  • Diagnostic sensitivity [Time frame: 1 year]
  • Diagnostic specificity [Time frame: 1 year]
  • CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions. [Time frame: 1 year]
  • Complication rate [Time frame: 1 month]

Eligibility criteria

Inclusion criteria

  • Age≥18 years;
  • Thin-slice chest CT showing GGO-dominant peripheral pulmonary lesions (diameter≥8mm, GGO component≥50%);
  • Suspected pulmonary malignant tumor which requires transbronchial lung biopsy for diagnosis;
  • Patients who have good compliance and sign informed consent.

Exclusion criteria

  • Diffuse GGO, suspected of benign or infectious lesions;
  • Preoperative imaging showing the target biopsy lesion adjacent to medium or large blood vessels;
  • Patients with contraindications of bronchoscopy;
  • Presence of concomitant endobronchial lesion during the bronchoscopy procedure;
  • Pregnant or lactating women;
  • Patients with known allergy for fluorescein;
  • The investigators believe that patient has other conditions that are not suitable for the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT06910046 · IS25061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗