CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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

Conditions

Peripheral Pulmonary Lesions (PPLs)

Being tested

Ex Vivo Confocal Laser Endomicroscopy (CLE) Imaging and Interpretation, Rapid On-Site Evaluation (ROSE) Imaging and Interpretation

Keywords

peripheral pulmonary lesions, Confocal Laser Endomicroscopy, Rapid On-Site Evaluation, Transbronchial Lung Biopsy, diagnosis

Medical subject headings

Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Ex Vivo Confocal Laser Endomicroscopy (CLE) Imaging and InterpretationDiagnostic test

  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.

• Rapid On-Site Evaluation (ROSE) Imaging and InterpretationDiagnostic test

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Diagnostic accuracy of ex vivo CLE versus ROSE for malignancy detection in peripheral pulmonary lesions

   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.

   Measured: Intraoperative - within 30 minutes of each biopsy specimen retrieval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted24 Jul 2026
2. Study start15 Jun 2026
3. Primary completion1 Dec 2027 (estimated)
4. Study completion1 Dec 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Peripheral Pulmonary Lesions (PPLs)Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.