Safety of Lung Cryobiopsy in People With Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2026-09-30

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.

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Transbronchial cryobiopsy

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.

Group Type EXPERIMENTAL

Transbronchial cryobiopsy

Intervention Type PROCEDURE

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.

Interventions

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Transbronchial cryobiopsy

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.

Intervention Type PROCEDURE

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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No