Safety of Lung Cryobiopsy in People With Cancer

Safety of Transbronchial Cryobiopsy in a Cancer Population

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04548830

Enrollment

115

Registered

2020-09-16

Start date

2020-09-08

Completion date

2026-06-30

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Cryobiopsy, 20-374

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.

Interventions

PROCEDURETransbronchial 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOROr Kalchiem-Dekel, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026