Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457087
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-08
Brief Title:
Optical Biopsy for Peripheral Pulmonary Lesions
Sponsor:
Shanghai Chest Hospital
Organization:
Shanghai Chest Hospital
Study Overview
Official Title:
Confocal Laser Endomicroscopy in the Diagnosis of Peripheral Pulmonary Lesions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to describe confocal laser endomicroscopy CLE interpretation criteria for different types of peripheral pulmonary lesions PPLs with histopathological correlation and to perform the validation of these criteria
Detailed Description:
CLE is a modern imaging technique that uses an excitation laser light to create real-time microscopic images of tissues During transbronchial lung biopsy CLE has the potential to provide real-time non-invasive diagnosis of PPLs optical biopsy In this study we will obtain CLE images within the target lesion before taking a biopsy during transbronchial lung biopsy of PPLs We will compare the results of the optical biopsy with the corresponding histopathological results and develop CLE interpretation criteria for different types of PPLs In addition we will perform the validation of these criteria to evaluate the ability of CLE to discriminate between benign and malignant PPLs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None