Clinical Utility of Needle-Based Confocal Laser Endomicroscopy for Peripheral Pulmonary Lesions
This prospective, multicenter diagnostic accuracy study will evaluate the clinical utility of needle-based confocal laser endomicroscopy (nCLE) for differentiating malignant from benign peripheral pulmonary lesions (PPLs). A total of 100 participants undergoing bronchoscopic evaluation of PPLs will be enrolled at three hospitals in China.
Following successful lesion localization using radial endobronchial ultrasound, nCLE imaging will be performed after intravenous administration of fluorescein, followed by standard bronchoscopic tissue sampling. nCLE findings will be compared with the final diagnosis established by histopathology, surgical pathology, or six-month clinical and imaging follow-up when necessary.
The primary outcomes are the sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy of nCLE. Procedure duration and procedure-related adverse events will also be recorded. The investigators hypothesize that nCLE can accurately distinguish malignant from benign PPLs in real time.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Zhongbo Chen
- Telefonnummer: 86+13777125910
- E-mail: leonczb@163.com
Studiesteder
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-
Hefei
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Hefei, Hefei, Kina, 230022
- Anhui Chest Hospital
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Kontakt:
- Fei Tang
- Telefonnummer: +86-13505696936
- E-mail: tangfei1205@163.com
-
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Ningbo
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Zhejiang, Ningbo, Kina, 315000
- The First Affiliated Hospital of Ningbo University
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Kontakt:
- ZHongbo Chen
- Telefonnummer: +86-13777125910
- E-mail: leonczb@163.com
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200030
- Shanghai Chest Hospital
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Kontakt:
- Jiayuan Sun
- Telefonnummer: +86-18017321598
- E-mail: jysun1976@163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- (1) Age 18 years or older. (2) A peripheral pulmonary lesion identified on chest CT. (3) Bronchoscopic biopsy considered clinically necessary by the treating physician to establish a pathologic diagnosis. (4) Willingness to undergo r-EBUS and nCLE examinations. (5) Voluntary participation with written informed consent.
Exclusion Criteria:
- (1) A contraindication to bronchoscopy, including severe cardiopulmonary disease, coagulation disorder, failure to discontinue anticoagulant therapy or anticoagulant medication for at least 5 days before the procedure, poor tolerance of anesthesia, psychiatric illness, or severe neurosis. (2) Pregnancy or breastfeeding. (3) Known allergy to fluorescein sodium. (4) Coagulation disorder. (5) A known allergic disorder, history of asthma, hepatic failure, renal failure, or another contraindication to fluorescein sodium injection. (6) Continued use of a systemic beta-blocker on the day of the procedure, or inability to discontinue the beta-blocker safely as assessed by the investigator and anesthesiologist. (7) Inability to cooperate with the study for any reason, or any other condition that the investigator considers unsuitable for enrollment.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Diagnostic Accuracy of Needle-Based Confocal Laser Endomicroscopy for Differentiating Malignant From Benign Peripheral Pulmonary Lesions
Tidsramme: Up to 6 months after the index bronchoscopy
|
Up to 6 months after the index bronchoscopy
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence and Severity of Procedure-Related Adverse Events
Tidsramme: Periprocedural
|
Periprocedural
|
|
Duration of the nCLE Procedure
Tidsramme: Periprocedural
|
Periprocedural
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Frequency of Guide-Sheath Adjustments Guided by Needle-Based Confocal Laser Endomicroscopy
Tidsramme: Periprocedural
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Periprocedural
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026-R324-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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