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Trial Title:
EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
NCT ID:
NCT06105801
Condition:
Lung Cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Endobronchial ultrasound with transbronchial needle aspiration
Description:
Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration
Arm group label:
EBUS-TBNA Group
Arm group label:
Transbronchial Mediastinal Cryobiopsy Group
Intervention type:
Procedure
Intervention name:
Bronchoscopy
Description:
Participants will undergo Bronchoscopy
Arm group label:
EBUS-TBNA Group
Arm group label:
Transbronchial Mediastinal Cryobiopsy Group
Intervention type:
Procedure
Intervention name:
Cryobiopsy
Description:
Participants will undergo Cryobiopsy
Arm group label:
Transbronchial Mediastinal Cryobiopsy Group
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. 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.
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).
Safety Endpoints:
- Pneumothorax within 7 days of procedure
- Moderate bleeding defined as controlled with bronchoscope, saline, or epinephrine
- Serious bleeding is defined as uncontrolled, leading to respiratory failure, need
for transfusion, or cardiovascular instability
- Respiratory failure is defined as a new oxygen requirement or escalation in oxygen
delivery within 7 days of procedure
- Unplanned hospitalization related to the procedure within 7 days of procedure
- Death
Exploratory Endpoints:
- The proportion of samples adequate for NGS testing
- The proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining
- Proportion of samples that are adequate for complete NGS library sequencing
- Estimated total number of tumor cells per H&E-stained slide
- Histological disease subtyping
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Vanderbilt University/Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vanderbilt-Ingram Service Services for Timely Access
Phone:
800-811-8480
Email:
cip@vumc.org
Investigator:
Last name:
Fabien Maldonado, MD
Email:
Principal Investigator
Start date:
September 13, 2024
Completion date:
October 31, 2028
Lead sponsor:
Agency:
Vanderbilt-Ingram Cancer Center
Agency class:
Other
Source:
Vanderbilt-Ingram Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06105801
