Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Comparing two methods for obtaining lung cancer tissue samples

Official title: A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing

Run by Vanderbilt-Ingram Cancer Center · NCT06105801 · Data updated 2026-11-12

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

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorVanderbilt-Ingram Cancer Center
Academic / other
Locations1 site (Nashville, Tennessee)
StatusRecruiting
StartedSeptember 13, 2024
Main results expectedOctober 31, 2027
Study endsOctober 31, 2028
Registry record updatedFebruary 2, 2026
Trial IDNCT06105801 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have explored similar biopsy techniques, but this specific comparison of cryobiopsy and EBUS-TBNA for next-generation sequencing adequacy is novel.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.