Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06910046

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CLE and ssRAB-guided cryobiopsy

Diagnostic Test

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 imaging, 2.5 ml of 10% fluorescein sodium is administered intravenously. CLE is then used to examine the target lesion. Based on real-time CLE imaging, the optimal biopsy location is identified and localized on the fluoroscopy. After CLE imaging, the CLE probe is retracted, followed by cryobiopsy at the same location under fluoroscopy guidance. Rapid on-site evaluation is available during the procedure to assess sample adequacy.

Primary outcomes

  1. Diagnostic yield

    Time frame: 1 year

    Diagnostic yield is defined as the number of diagnostic lesions divided by the total number of lesions.

Secondary outcomes

  1. Diagnostic accuracy

    Time frame: 1 year

    Diagnostic accuracy is calculated according to the standard definition using the classical 2*2 table.

  2. Diagnostic sensitivity

    Time frame: 1 year

    Diagnostic sensitivity is calculated according to the standard definition using the classical 2*2 table. Malignancy is considered as positive.

  3. Diagnostic specificity

    Time frame: 1 year

    Diagnostic specificity is calculated according to the standard definition using the classical 2*2 table. Malignancy is considered as positive.

  4. CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions.

    Time frame: 1 year

    The CLE interpretation criteria for different kinds of GGO-dominant PPLs and the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the proposed criteria in differentiating benign from malignant lesions.

  5. Complication rate

    Time frame: 1 month

    The complications refer to the total of device or procedure related adverse events during or within 1 month after the operation.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiayuan Sun, MD, PhD

CONTACT

[email protected]

86-021-22200000 ext. 1511

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.