CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment
A Comparative Study on the Diagnostic Efficacy of Confocal Laser Endomicroscopy Versus Rapid On-Site Evaluation (ROSE) for Ex Vivo Lung Biopsy Specimens Obtained Via Bronchoscopy
The goal of this observational study is to evaluate the diagnostic efficacy of Confocal Laser Endomicroscopy (CLE) compared to Rapid On-Site Evaluation (ROSE) for ex vivo lung biopsy specimens obtained via bronchoscopy. The main questions it aims to answer are:
- Does CLE provide diagnostic accuracy comparable to ROSE for the real-time assessment of peripheral pulmonary lesions?
- What is the level of consistency between CLE-detected malignant architectural patterns and ROSE-identified atypical cells? Participants with peripheral pulmonary lesions (5-50 mm) undergoing navigational bronchoscopy will have their first retrieved biopsy specimen sequentially analyzed. The specimen will undergo CLE scanning first, followed immediately by ROSE cytology, before being fixed for final histopathological examination (the gold standard). CLE and ROSE interpreters will be blinded to the final pathological results and to each other's findings. Diagnostic performance, inter-modality agreement (using Kappa statistics), and procedure times will be analyzed to determine if CLE can serve as a non-consumptive alternative to ROSE.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: ZhenDing You
- Telefonnummer: +86 020-81566640
- E-Mail: youzhending@163.com
Studienorte
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Guangdong
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Guangzhou, Guangdong, China, 510100
- Rekrutierung
- The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163
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Kontakt:
- ZhenDing You, Master
- Telefonnummer: 020-81566640
- E-Mail: youzhending@163.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
This study will enroll 60 adult participants with newly identified peripheral pulmonary lesions (PPLs) who are scheduled to undergo diagnostic navigational bronchoscopy. The target population consists of patients presenting with solitary or multiple pulmonary nodules or masses ranging from 5 to 50 mm in maximum diameter on computed tomography (CT) imaging, who have a clinical indication for tissue diagnosis.
All participants must be surgical candidates fit enough to tolerate flexible bronchoscopy and meet standard pre-procedural coagulation parameters. Pregnant or lactating women, as well as individuals with severe cardiopulmonary insufficiency or uncorrectable coagulopathy, will be excluded to ensure procedural safety. Written informed consent will be obtained from all participants prior to enrollment. The study population is specifically selected to evaluate the diagnostic efficacy of novel optical biopsy (CLE) against the current standard (ROSE) in lesions where tissue acquisition
Beschreibung
Inclusion Criteria:
（1）Imaging Findings: Presence of a peripheral pulmonary lesion (PPL) measuring 5 to 50 mm in maximum diameter on chest CT scan.
（2）Clinical Indication: Patients with a clinical indication for diagnostic flexible bronchoscopy and transbronchial biopsy.
（3）Consent: Provision of signed and dated written informed consent prior to any study-specific procedures.
Exclusion Criteria:
（1）Contraindications to Bronchoscopy: Patients with severe cardiopulmonary insufficiency or any absolute contraindication to flexible bronchoscopy (e.g., severe hypoxemia, unstable angina, or uncontrolled asthma).
（2）Coagulopathy: Patients with severe coagulation disorders (e.g., platelets <50,000/μL, INR >1.5) not corrected prior to the procedure.
（3）Pregnancy/Lactation: Pregnant or lactating women.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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CLE Group
Ex Vivo Confocal Laser Endomicroscopy (CLE) Imaging and Interpretation
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Following navigational bronchoscopy and target confirmation via radial endobronchial ultrasound (r-EBUS) and in vivo CLE, a lung biopsy is performed.
The first retrieved specimen is immediately transferred to the CLE workstation.
A CLE expert measures the specimen dimensions and then performs a comprehensive surface scan of the intacttissue using a confocal miniprobe.
The operator records the time required for setup and imaging.
Based exclusively on the real-time microarchitectural patterns (e.g., loss of normal alveolar honeycombing, dense cell clusters), the blinded CLE expert renders a preliminary diagnosis of "benign" or "malignant."
Crucially, this intervention is non-consumptive, meaning the tissue remains physically intact and structurally preserved after the scan for the subsequent ROSE procedure.
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ROSE Group
Rapid On-Site Evaluation (ROSE) Imaging and Interpretation
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Immediately following the completion of the ex vivo CLE imaging on the same biopsy specimen, the tissue undergoes ROSE processing.
A ROSE expert (cytopathologist) performs a smear preparation using the CLE-scanned tissue.
The specimen is then stained (e.g., Diff-Quik) and evaluated microscopically.
The operator records the time required for smear preparation, staining, and interpretation.
The blinded ROSE expert assesses the presence of atypical cells or diagnostic material to render a cytological diagnosis of "benign" or "malignant."
Unlike the preceding CLE step, this intervention is consumptive, as it requires the physical disruption of the tissue architecture to transfer cellular material onto glass slides.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Diagnostic accuracy of ex vivo CLE versus ROSE for malignancy detection in peripheral pulmonary lesions
Zeitfenster: Intraoperative - within 30 minutes of each biopsy specimen retrieval
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Using final histopathology as the gold standard, diagnostic accuracy (proportion of correct benign/malignant classifications) will be calculated for both ex vivo confocal laser endomicroscopy (CLE) and rapid on-site evaluation (ROSE).
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy with 95% confidence intervals will be derived from 2×2 contingency tables for each modality.
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Intraoperative - within 30 minutes of each biopsy specimen retrieval
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Diagnostic performance of ex vivo CLE
Zeitfenster: Intraoperative
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Using final histopathology as the gold standard, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ex vivo confocal laser endomicroscopy (CLE) for detecting malignancy will be calculated, along with 95% confidence intervals.
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Intraoperative
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Diagnostic performance of ROSE
Zeitfenster: Intraoperative
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Using final histopathology as the gold standard, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ROSE will be calculated based on touch imprint cytology performed after CLE imaging.
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Intraoperative
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Cohen's kappa (κ) for agreement between CLE diagnosis and final histopathology
Zeitfenster: After final pathology available (within 7-10 working days)
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Measures inter-rater/modality concordance beyond chance agreement.
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After final pathology available (within 7-10 working days)
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Cohen's kappa (κ) for agreement between CLE structural findings and ROSE cytological findings on the same specimen
Zeitfenster: Intraoperative interpretations, validated post-pathology
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Cross-validation of malignant architectural patterns (CLE) vs. presence of atypical cells (ROSE).
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Intraoperative interpretations, validated post-pathology
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Procedure time: CLE imaging and interpretation time per specimen
Zeitfenster: Intraoperative
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Measured in seconds/minutes from probe placement to definitive optical diagnosis.
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Intraoperative
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Procedure time: ROSE preparation and interpretation time per specimen
Zeitfenster: Intraoperative
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Measured in seconds/minutes from touch imprint/smear to definitive cytological diagnosis.
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Intraoperative
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Mitarbeiter und Ermittler
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Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ES-2025-229-01
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