Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

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.

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.

Transbronchial cryobiopsy

Bryan Husta, MD

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.

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.

Safety of Lung Cryobiopsy in People With Cancer

Safety of Transbronchial Cryobiopsy in a Cancer Population

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

will be graded according to Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)

Memorial Sloan Kettering Cancer Center

Multiple Pulmonary Nodules

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients receive a transbronchial cryobiopsy using an eBUS cryo probe

patients receive a transbronchial cryo biopsy with the EBUS cryo probe from ERBE and an ultra thin bronchoskope

EBUS cryo probe

Ralf Eberhardt, Prof. Dr. med.

The standard procedure in the diagnosis of peripheral round foci is bronchoscopy with transbronchial forceps biopsy (TBB). Despite the simultaneous application of X-ray fluoroscopy, the diagnostic value of this method depends strongly on the size, location and relationship of the foci to the airways as well as their radiological representability. By inserting radial 20 MHz ultrasound probes through the working channel of a flexible bronchoscope into the periphery of the lung, the detection of peripheral foci can be improved. By simultaneously using a virtual bronchoscopy with an ultra-thin bronchoscope, even smaller round foci in the periphery of the lung can be detected. For some years now, tension-resistant cryoprobes have been used for transbronchial biopsy. Here, especially in lesions that can only be reached endoscopically tangentially, advantages have been shown over forceps biopsy. Much larger tissue samples can be obtained without increasing the complication rate. Studies showed that the combination of the EBUS navigation technique with the cryobiopsy procedure is feasible and safe in the endoscopic diagnosis of peripheral lung tumors. This study investigates to what extent the combination of an ultra-thin cryoprobe with an ultra-thin bronchoscope together with the radial EBUS can further improve the diagnosis. This study is a non-randomized pilot study to prove the feasibility of this procedure. The EBUS probe and the bronchoscope are CE certified for this application. The study will be conducted as a monocentric study at the Thorax Clinic at Heidelberg University Hospital.

A total of 30 patients with an indication for transbronchial biopsy will be prospectively included. All patients will be examined according to the clinical standard. After a freezing time of 3-7 seconds, the probe together with the bronchoscope will be extracted and the sample will be defrosted in a water-filled sample vial. Up to 4 biopsies will be taken depending on the investigator's assessment. The samples will be collected separately and the order of the biopsies will be recorded. The primary endpoint is the feasibility of the procedure. Secondary endpoints are safety, diagnostic hit rate, biopsy size and quality and success rate depending on the position of the EBUS probe (tangential or central).

EBUS Guided Cryobiopsies With Ultrathin Cryoprobe in Patients With Peripheral Pulmonary Nodules - a Feasibility Study

Pathological assessment of biopsies for ILD diagnosis

Assessed by using a stop watch and entering data into a questionnaire

Assessment of exacerbations until 4 weeks after biopsy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety of Lung Cryobiopsy in People With Cancer	NCT04548830	Lung Cancer	Transbronchial ...	18 Years -	Memorial Sloan Kettering Cancer Center
Safety of Lung Cryobiopsy in People With Cancer	NCT04548830	Lung Cancer	Transbronchial ...	18 Years -	Memorial Sloan Kettering Cancer Center
EBUS Guided Cryobiopsies With Ultrathin Cryoprobe in Patients With Peripheral Pulmonary Nodules - a Feasibility Study	NCT04471324	Transbronchial ...	EBUS cryo probe	18 Years -	Thoraxklinik-Heidelberg gGmbH

Spots Global Cancer Trial Database for transbronchial cryobiopsy