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Procedure

Confocal Laser Endomicroscopy for Lung Cancer (CLEVER Trial)

N/A
Recruiting
Led By Jouke Annema, Prof. dr.
Research Sponsored by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Suspected malignant peripheral lung lesion with an indication for a bronchoscopic diagnostic work-up
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after all patients have been included (expected total time frame 2 years)
Awards & highlights

Summary

This trial is trying to determine if using a needle-based imaging technique called confocal laser endomicroscopy (nCLE) during a bronchoscopy procedure can improve the accuracy of diagnosing lung nod

Who is the study for?
This trial is for adults over 18 with suspected malignant lung lesions suitable for bronchoscopic diagnosis. The lesion must be solid, larger than 10mm but not exceeding 30mm, and accessible by conventional bronchoscopy as indicated by a CT scan. Participants must understand and consent to the study.
What is being tested?
The trial tests if adding needle-based confocal laser endomicroscopy (nCLE) to regular diagnostic bronchoscopy improves the chances of correctly diagnosing lung cancer in patients with peripheral pulmonary nodules.
What are the potential side effects?
While specific side effects are not listed, nCLE involves imaging during bronchoscopy which may increase procedure time and could potentially lead to complications related to longer bronchoscopies such as discomfort or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
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I am suspected to have lung cancer and need a lung biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after all patients have been included (expected total time frame 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and after all patients have been included (expected total time frame 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostic yield (intermediate definition)
Secondary study objectives
Additional diagnostics needed
Complication rate
Diagnostic sensitivity
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: nCLE armExperimental Treatment2 Interventions
Diagnostic bronchoscopy is done according to institutional practice with the addition of nCLE
Group II: Control armActive Control1 Intervention
Diagnostic bronchoscopy is done according to institutional practice without the addition of nCLE

Find a Location

Who is running the clinical trial?

Mauna Kea TechnologiesIndustry Sponsor
19 Previous Clinical Trials
1,604 Total Patients Enrolled
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)Lead Sponsor
14 Previous Clinical Trials
7,173 Total Patients Enrolled
Jouke Annema, Prof. dr.Principal InvestigatorAmsterdam UMC
~104 spots leftby Oct 2025
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