Safety of Lung Cryobiopsy in People With Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Safety of Transbronchial Cryobiopsy in a Cancer Population

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Transbronchial cryobiopsy


Participation Criteria
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Eligibility Criteria
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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 FVC <50% of the predicted value, DLCO <30% of the predicted value or FEV1 <0.8L 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single center investigator initiated study for patients who display indeterminant pulmonary nodules and diffuse parenchymal lung disease on CT chest imaging who have been referred to the Pulmonary service.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transbronchial cryobiopsy<br>All study participants will undergo transbronchial biopsies via our proposed standardized cryo-biopsy protocol in place of the traditional forceps transbronchial biopsy that is typically used at MSK. | Procedure: Transbronchial cryobiopsy<br>* After enrollment, and pre-treatment procedures are complete, patients will undergo flexible bronchoscopy with a therapeutic bronchoscope under general anesthesia via an advanced airway at Memorial Hospital in an inpatient or outpatient setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Cryobiopsy complications | will be graded according to Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryobiopsy, 20-374