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

No Placebo-Only Group

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.

Select...

I am suspected to have lung cancer and need a lung biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after all patients have been included (expected total time frame 2 years)

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.