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

Lung Cancer Clinical Trial

— META-Gen  

Official title:

A Multicenter Randomized Trial of EBUS-TBNA Versus EBUS-TBNA Plus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing the META-Gen Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06105801
• Other study ID #: VICC-VDTHO23177
• Secondary ID: NCI-2023-08954
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 31, 2024
• Est. completion date: October 31, 2028

Study information

• Verified date: April 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: Vanderbilt-Ingram Services for Timely Access
• Phone: 800-811-8480
• Email: cip[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, clinical trial evaluating the effect of adding transbronchial mediastinal cryobiopsy to EBUSTBNA 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 acquisition of tissue for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE of a mediastinal 8 lymph node or mass suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a transbronchial mediastinal cryobiopsy.

Description:

Primary Objective:

• To evaluate the utility of adding transbronchial mediastinal cryobiopsy to endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) 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:

• 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: October 31, 2028
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mediastinal lesion (lymph node or mass) on endobronchial ultrasound (EBUS) and/or PET/CT concerning for primary or metastatic malignancy

• 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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• Endobronchial ultrasound with transbronchial needle aspiration
Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration
• Bronchoscopy
Participants will undergo Bronchoscopy
• Cryobiopsy
Participants will undergo Cryobiopsy

Locations

Country	Name	City	State
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of samples sufficient for next-generation sequencing testing	Comparison of samples between arms that meet sufficiency criteria for NGS	Up to 12 months
Secondary	Proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining	Comparison of samples between arms that meet PD-1/PD-L1 adequacy	Up to 12 months
Secondary	Proportion of samples that are adequate for complete NGS library sequencing	Comparison of samples between arms that meet sufficiency criteria and then are adequate for complete NGS library sequencing	Up to 12 months
Secondary	Estimated total number of tumor cells per H&E-stained slide	Comparison of samples between arms of estimated tumor cells per H&E-stained field	Up to 12 Months
Secondary	Histological disease subtyping	Comparison of samples between arms for subtypes of lung malignancies (primary or metastatic)	Up to 12 Months