NCT06105801RecruitingPhase 4
EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
This is a multi-center clinical trial evaluating the effect of transbronchial mediastinal cryobiopsy for its ability to improve the likelihood of obtaining tissue sufficient for molecular analysis. Patients in outpatient clinics or pre-operative holding areas planning to undergo a bronchoscopic biopsy of a suspected malignant lesion (peripheral or mediastinal) for initial diagnosis, staging, or tissue acquisition for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a sampling.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 23 Oct 2023
- Start date
- 13 Sept 2024
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Diseases
- Lung cancer
- NCT number
- NCT06105801
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 250
- From 13 Sept 2024 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Patient is known to be less than 18 years old
Other
- Patient is known to be pregnant
- Patient is known to be a prisoner
- Operator deems lesion is not safe to biopsy
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.