Health TrialsbyHealthPanel

Diagnosing peRipheral Lung Lesions With CRYO Biopsies

ConditionsLung CancerPeripheral Lung Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Patients undergoing diagnostic work-up for lung cancer due to a lung lesion surrounded by normal lung tissue (identified by CT)

Age 18 or above

Bronchoscopy with planned forceps sampling from the lesion

Disqualifiers

- Pregnancy

Not able to provide informed consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • forceps biopsies

    Diagnostic test

    5 forceps biopsies

  • Cryo biosies

    Diagnostic test

    5 cryo biopsies

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 2 interventions
Group B: InterventionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Diagnostic yield

\- Total diagnostic yield, being defined as a tissue biopsy allowing a definite diagnosis of either a malignant or benign condition in the lung in proportion to the total number of procedures performed.

Time frame
One week after initial study procedure

Secondary outcomes

1

Malignant yield

Diagnostic yield of malignant conditions, being defined as a tissue biopsy allowing a definite diagnosis of a malignant condition in the lung

Time frame
One year after initial study procedure
2

Benign yield

Diagnostic yield of non-malignant conditions, being defined as a tissue biopsy allowing a definite diagnosis of a benign condition in the lung

Time frame
One year after initial study procedure
3

NGS testing

Proportion of patients with sufficient biopsy material for NGS testing

Time frame
One week after initial study procedure
4

Complications

Total proportion of patients with procedure complications

Time frame
One week after bronchoscopy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Odense University Hospital

Lead sponsor

University of Southern Denmark

Collaborator

Source ClinicalTrials.gov
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