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Diagnosing peRipheral Lung Lesions With CRYO Biopsies

NCT06844344 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-20

No results posted yet for this study

Summary

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 .

Conditions

Interventions

DIAGNOSTIC_TEST

forceps biopsies

5 forceps biopsies

DIAGNOSTIC_TEST

Cryo biosies

5 cryo biopsies

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-02-01
Completion
2027-02-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06844344 on ClinicalTrials.gov