Lung CancerDR CRYONCT06844344
Diagnosing peRipheral Lung Lesions With CRYO Biopsies
A study testing forceps biopsies and Cryo biosies in people with Lung Cancer and Peripheral Lung Lesions, run by Odense University Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Peripheral Lung Lesions
- What is being tested?
- forceps biopsies and Cryo biosies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Mar 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- - Pregnancy
- Not able to provide informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christian B Laursen, MD, Professor contact
Denmark2 sites, 2 recruiting
- Not yet recruiting
Næstved Hospital
Næstved, Region Sjælland, 4700
Uffe Bødtger, MD, Professor, +4556513966
Uffe Bødgter, MD, Professor
- Recruiting
Odense University Hospital
Odense, Region Syddanmark, 5000
Amanda D Juul, +4565412727, amanda.dandanell.juul@rsyd.dk
amanda d juul
About this study
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 .
Read the detailed description
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:
- Larger biopsies (i.e., cryo biopsies) will increase the diagnostic yield by allowing for sub-optimal sampling position
- 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
- Using the 1.1 freezing probe for diagnosing malignancy is safe and feasible under conscious sedation.
Objectives:
- Compare the diagnostic yield of cryo biopsies with forceps biopsies in lesions suspected of malignancy
- Compare the benign yield/ malignant yield of cryo biopsies with forceps biopsies
- Compare the number of samples with sufficient material for Next Generation Sequencing (NGS) testing
- Assess the safety of using the 1.1 mm freezing probe without general anesthesia, tracheal tube or endobronchial blocker.
- 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
- Lung Cancer, Peripheral Lung Lesions
- Being tested
- forceps biopsies, Cryo biosies
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forceps biopsiesDiagnostic test
5 forceps biopsies
Cryo biosiesDiagnostic test
5 cryo biopsies
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 5 forceps biopsies followed by 5 cryo biopsies Receives: Diagnostic Test: forceps biopsies; Diagnostic Test: Cryo biosies |
| Intervention | Experimental | 5 Cryo biopsies follwed by 5 forcepsbiopsies Receives: Diagnostic Test: forceps biopsies; Diagnostic Test: Cryo biosies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week after initial study procedure
Secondary outcomes (7)
Malignant yield
Diagnostic yield of malignant conditions, being defined as a tissue biopsy allowing a definite diagnosis of a malignant condition in the lung
Measured: One year after initial study procedure
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
Measured: One year after initial study procedure
NGS testing
Proportion of patients with sufficient biopsy material for NGS testing
Measured: One week after initial study procedure
Complications
Total proportion of patients with procedure complications
Measured: One week after bronchoscopy
Serious procedure complications
Total proportion of patients with severe procedure complications
Measured: One week after bronchoscopy
Feasibility of procedure
Feasibility of procedure (proportion of procedures: not commenced, aborted due to respiratory failure, excessive coughing, inability to cooperate with the procedure, lesion not found, less than 10 forceps biopsies, less than 5 cryo biopsies
Measured: Same day as the study procedure
tissue grading score
The study will be using the "scoring system for specimen quality" https://doi.org/10.1159/000531010
The study will assess the difference in mean or median tissue score. Min value 1, Maximum value 6. "1" represents the worst tissue specimen and "6" represents the best tissue specimen.
Measured: One week after initial study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Amanda Dandanell Juul, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844344
- Sponsor's protocol ID
- S-20240032
- Acronym
- DR CRYO
- Status last verified
- May 2026
- First submitted
- 23 Jan 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to patient confidentiality and the possibility to identify individual patients based on sensitive information.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing peRipheral Lung Lesions With CRYO Biopsies
- ClinicalTrials.gov ID
- NCT06844344
- Acronym / sponsor ID
- DR CRYO / S-20240032
- Conditions
- Lung Cancer, Peripheral Lung Lesions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
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:
- Larger biopsies (i.e., cryo biopsies) will increase the diagnostic yield by allowing for sub-optimal sampling position
- 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
- Using the 1.1 freezing probe for diagnosing malignancy is safe and feasible under conscious sedation.
Objectives:
- Compare the diagnostic yield of cryo biopsies with forceps biopsies in lesions suspected of malignancy
- Compare the benign yield/ malignant yield of cryo biopsies with forceps biopsies
- Compare the number of samples with sufficient material for Next Generation Sequencing (NGS) testing
- Assess the safety of using the 1.1 mm freezing probe without general anesthesia, tracheal tube or endobronchial blocker.
- 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] .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Diagnostic Test: forceps biopsies, Diagnostic Test: Cryo biosies5 forceps biopsies followed by 5 cryo biopsies |
| Intervention | Experimental | Diagnostic Test: forceps biopsies, Diagnostic Test: Cryo biosies5 Cryo biopsies follwed by 5 forcepsbiopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - 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
Key exclusion criteria (2 listed)
- - Pregnancy
- Not able to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| forceps biopsies5 forceps biopsies | Diagnostic test | Control, Intervention |
| Cryo biosies5 cryo biopsies | Diagnostic test | Control, Intervention |
Primary outcome
Diagnostic yield
Time frame: One week after initial study procedure
- 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.
7 secondary outcomes
Malignant yield
Time frame: One year after initial study procedure
Benign yield
Time frame: One year after initial study procedure
NGS testing
Time frame: One week after initial study procedure
Complications
Time frame: One week after bronchoscopy
Serious procedure complications
Time frame: One week after bronchoscopy
Feasibility of procedure
Time frame: Same day as the study procedure
tissue grading score
Time frame: One week after initial study procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to patient confidentiality and the possibility to identify individual patients based on sensitive information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian B Laursen, MD, Professor contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing forceps biopsies and Cryo biosies in people with Lung Cancer and Peripheral Lung Lesions, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda D Juul, MD, PhD (+4565412727, amanda.dandanell.juul@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: One week after initial study procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.