Comparing two methods for obtaining lung cancer tissue samples
A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
This study is testing which method, cryobiopsy or EBUS-TBNA, is better at getting enough lung cancer tissue samples for testing in patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06105801 on ClinicalTrials.gov |
What this trial studies
This multi-center clinical trial evaluates the effectiveness of transbronchial mediastinal cryobiopsy compared to endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) in acquiring sufficient tissue for molecular analysis in lung cancer patients. Participants will be randomized to receive either the standard EBUS-TBNA or the cryobiopsy method during their bronchoscopic biopsy procedure. The study aims to determine which method yields a higher proportion of adequate samples for next-generation sequencing and assesses safety endpoints related to the procedures.
Who should consider this trial
Good fit: Ideal candidates are adults with suspected malignant lung lesions that are amenable to biopsy and have shown malignant cells on rapid on-site cytological evaluation.
Not a fit: Patients who are under 18 years old, pregnant, or whose lesions are deemed unsafe for biopsy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of lung cancer diagnoses and treatment planning through improved tissue sampling techniques.
How similar studies have performed: Other studies have explored similar biopsy techniques, but this specific comparison of cryobiopsy and EBUS-TBNA for next-generation sequencing adequacy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Lesions on PET or CT concerning for primary or metastatic malignancy that are amenable to biopsy by linear EBUS * Malignant cells present on rapid on-site cytological evaluation (ROSE) Exclusion Criteria: * Patient is known to be less than 18 years old * Patient is known to be pregnant * Patient is known to be a prisoner * Operator deems lesion is not safe to biopsy
Where this trial is running
Nashville, Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Fabien Maldonado, MD — Vanderbilt University/Ingram Cancer Center
- Study coordinator: Vanderbilt-Ingram Services for Timely Access
- Email: cip@vumc.org
- Phone: 800-811-8480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.