Status:
NOT_YET_RECRUITING
GGO-dominant PPLs Diagnosis Using CLE and ssRAB-guided Cryobiopsy
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Lung Ground-Glass Opacity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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-sens...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT06910046
Start Date
April 1 2025
End Date
April 1 2027
Last Update
April 6 2025
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030