Safety of Transbronchial Cryobiopsy in a Cancer Population

Memorial Sloan Kettering Cancer Center1 site in 1 country100 target enrollmentSeptember 8, 2020

ConditionsLung Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 100
Locations: 1
Primary Endpoint: Post Cryobiopsy complications
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to find out whether a biopsy technique called transbronchial cryobiopsy (TBCB) is a safe alternative to the standard biopsy procedure (transbronchial forceps biopsy; TBFB). The study researchers think that TBCB may provide better biopsy samples to help diagnose lung disease.

Registry

clinicaltrials.gov

Start Date

September 8, 2020

End Date

September 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years of age or greater
•Patients with known or suspected diagnosis of cancer and indeterminant pulmonary nodules or diffuse parenchymal lung disease with non-diagnostic clinical profiles for whom a lung biopsy is deemed useful for diagnosis.

Exclusion Criteria

•Patients with pulse oximetry less than 92% on oxygen delivery up to 2 L nasal cannula.
•Uncorrectable coagulopathy defined as:
•Platelet count \<50,000 x 10\^9/L or
•prothrombin time international normalized ratio \>1.5
•Known pulmonary hypertension or echocardiographic pulmonary artery systolic pressure \>50mmHg
•A secure diagnosis based on clinical and high-resolution CT scan data.
•Antiplatelet therapy that cannot be held for more than 5 days.
•Any patient deemed unfit to undergo bronchoscopy by the proceduralist
•Female patients with a positive pregnancy test within 30 days of the planned study procedure