Diagnosing peRipheral Lung Lesions With CRYO Biopsies

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Lung cancer is the leading course of cancer related deaths world-wide. Lung cancer screening will increase the number of small lung lesion in need of biopsy to confirm the diagnosis. Obtaining lung biopsies with a bronchoscopy has the lowest risk of complications (1-2%) compared to other modalities such as transthoracic needle biopsy (20%), however diagnostic yield needs improvement. Currently a diagnosis is established in 50- 70% of the bronchoscopic procedures depending on the step-up. One way to improve the yield would be by using a cryo probe through the bronchoscope which freezes a small part of the lung for extraction, and thereby provides larger biopsies for examination. This will increase the chances of obtaining sufficient material from a small lesion to determine the diagnosis.

The DR CRYO study will compare cryo biopsies to forceps biopsies for the diagnosis of peripheral lung lesions.

We hope that the cryo biopsies can improve the diagnostic capabilities of bronchoscopy and provide better biopsies for tumor marker analyses. The project is relevant both for patients undergoing diagnostic work-up for lung cancer in early stages .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases

NCT02235779

Interstitial Lung Disease

UNKNOWN NA

Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study

NCT02464592

Lung Diseases, Interstitial

COMPLETED NA

Cryobiopsy Vs. Forceps Biopsy for Peripheral Pulmonary Lesions

NCT06752395

Lung Cancer (NSCLC)

ENROLLING_BY_INVITATION NA

CrYobiopsy With Radial UltraSound Guidance

NCT03506295

Pulmonary Disease

COMPLETED NA

Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.

NCT01894113

Interstitial Lung Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background:

Lung cancer is currently the leading cause of cancer related deaths world-wide \[1\]. Approximately 5000 people are diagnosed with lung cancer each year in Denmark \[2\]. Lung cancer is often detected in late stages of the disease, which are rarely curable and have a poor prognosis \[3\]. Currently, early stages of lung cancer are often detected incidentally on a computed tomography (CT) scan as a solitary lung lesion \[4\]. Screening for lung cancer has the possibility to reduce lung cancer mortality, however a screening program will produce a large increase in CT scans with lung lesions \[5, 6\]. Tissue sampling is one of the corner stones for correctly diagnosing cancer in a patient. Obtaining tissue from the lungs is challenging since the lungs are difficult to access and biopsies comes with risk of complications.

Tissue samples can be acquired either by removing part of the lung surgically, by performing a needle biopsy through the chest wall or by using a bronchoscope (i.e. by endoscopy)-. The latter has the lowest risk of complications, but currently the diagnostic yield is lower than the other two methods. The low risk profile is an advantage in an increasing elderly population, where improvements in the diagnostic capabilities would be of great value to the patients.

Cryo freezing probes enable sampling from the lung parenchyma by freezing a small tissue area which is then extracted via the bronchoscope. The technology was initially invented to provide larger tissue samples for the diagnosis of interstitial lung disease, but may also be of great value for collecting tissue from cancerous disease since cryo biopsies are generally larger and less crushed than traditional biopsies.

Few studies regarding cryo biopsy for sampling cancer in the lungs exists, however initial trials demonstrates higher diagnostic yield and an increase in sufficient material for tumor marker analysis\[9, 10\].

Hypothesis:

1. Larger biopsies (i.e., cryo biopsies) will increase the diagnostic yield by allowing for sub-optimal sampling position
2. Cryo biopsies are larger and less crushed than forceps biopsies and could therefore increase benign yield to rule out cancer in patients with cancer suspected lesions
3. Using the 1.1 freezing probe for diagnosing malignancy is safe and feasible under conscious sedation.

Objectives:

1. Compare the diagnostic yield of cryo biopsies with forceps biopsies in lesions suspected of malignancy
2. Compare the benign yield/ malignant yield of cryo biopsies with forceps biopsies
3. Compare the number of samples with sufficient material for Next Generation Sequencing (NGS) testing
4. Assess the safety of using the 1.1 mm freezing probe without general anesthesia, tracheal tube or endobronchial blocker.
5. Develop a grading system for endoscopic biopsies to ensure standardized and reproducible assessment.

Method:

This study will be conducted as a randomized clinical trial according to CONSORT guidelines (multicenter) study at Center for Lung Cancer at Odense University Hospital, Bispebjerg Hospital, and Næstved Hospital in collaboration with the Department of Pathology at Odense University Hospital \[11\] .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Peripheral Lung Lesions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this study we will compare the diagnostic yield of forceps biopsies to cryo biopsies.

All patient will receive both cryo biopsies and forceps biopsies however the order of the biopsies will be randomized.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.