Status:

RECRUITING

EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing

Lead Sponsor:

Vanderbilt-Ingram Cancer Center

Collaborating Sponsors:

Northwestern Medicine

Johns Hopkins University

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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. Pa...

Detailed Description

Primary Objective: \- To evaluate the utility of transbronchial mediastinal cryobiopsy on its ability to improve the likelihood of acquiring tissue sufficient for next-generation sequencing (NGS). S...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 13 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 31 2028

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT06105801

Start Date

September 13 2024

End Date

October 31 2028

Last Update

May 25 2025

Active Locations (1)

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Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37232