Lung Cancer (NSCLC)NCT06921681
Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes
A study testing Cryobiopsy of lymph nodes group 6 sec and Cryobiopsy lymphnode group 3 sec in people with Lung Cancer (NSCLC), run by University of Zurich at 1 site in Switzerland.
Trial summary
EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Cryobiopsy of lymph nodes group 6 sec and Cryobiopsy lymphnode group 3 sec
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Mar 2025to 31 Dec 2029
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one mediastinal lesion or hilar 1 cm or longer in the short axis requiring diagnostic bronchoscopy
- Age between 18 and 90 years
- Written informed consent after participant's information
Who cannot join
- Age < 18 and > 90 years
- Lacking ability to form an informed consent (including impaired judgement, communication barriers)
- Contraindication against bronchoscopy (e.g. co-morbidities)
- Mediastinal abscess or cyst
- Extraordinary blood supply of the lesion visualized by EBUS bronchoscope
- INR > 1.5 or Thrombocytes < 100 G/l
Show all 9Show fewer
- Clopidogrel or other new antiplatelet drugs within 7 days before biopsy (salicylic acid alone allowed)
- Anticoagulation with NOAC within 48 hours before biopsy
- Pulmonary lesions suspicious of lung carcinoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Jürgen Hetzel
Basel
Jürgen Hetzel, +41 61 265 51 84, juergen.hetzel@usb.ch
Jahn Kathleen
About this study
Official title: Transbronchial EBUS-guided TBNA and Cryobiopsy of Mediastinal Lymph Nodes in Patients Nonsuspicious for Lung Cancer, Using Different Cryoprobe Freezing Times
EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information.
Read the detailed description
EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information. This study will analyze whether the freezing time influences the diagnostic yield in CB of mediastinal lymphadenopathies. Additionally we will evaluate the influence of the number of biopsies on the diagnostic yield.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Cryobiopsy of lymph nodes group 6 sec, Cryobiopsy lymphnode group 3 sec
- Keywords
- EBUS, Cryobiopsy, TBNA, Bronchoscopy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryobiopsy of lymph nodes group 6 secDevice
Included patients receive transbronchial access with EBUS needle (19, 21 or 22 gauge needle) Hereafter, three times EBUS-TBNA followed by four EBUS-guided-CBs with a 1.1mm cryoprobe will be performed. Included patients are 1:1 randomized to receive CB with cryoprobe activated for either 3 sec of freezing time (group "3sec") or 6 sec. of freezing time (group "6sec") before the biopsy together with the whole EBUS bronchoscope is extracted. The EBUS-guided CB will be conducted four times in each group. Aiming access to one lymph node if one lymph node cannot be punctured, another lymph node will be chosen. Even if tissue-extraction out of a lymph node via cryoprobe fails once to several times, overall no more than 4 attempts for cryobiopsy will be done
Cryobiopsy lymphnode group 3 secDevice
Included patients receive transbronchial access with EBUS needle (19, 21 or 22 gauge needle) Hereafter, three times EBUS-TBNA followed by four EBUS-guided-CBs with a 1.1mm cryoprobe will be performed. Included patients are 1:1 randomized to receive CB with cryoprobe activated for either 3 sec of freezing time (group "3sec") or 6 sec. of freezing time (group "6sec") before the biopsy together with the whole EBUS bronchoscope is extracted. The EBUS-guided CB will be conducted four times in each group. Aiming access to one lymph node if one lymph node cannot be punctured, another lymph node will be chosen. Even if tissue-extraction out of a lymph node via cryoprobe fails once to several times, overall no more than 4 attempts for cryobiopsy will be done
| Study group | Role | What they receive |
|---|---|---|
| group 6 sec | Active comparator | EBUS-guided CBs of mediastinal/hilar lymph nodes will be done with 6 seconds of cryoprobe freezing time ("group 6sec.") before the biopsy together with the whole EBUS bronchoscope is extracted. Receives: Device: Cryobiopsy of lymph nodes group 6 sec |
| group 3 sec | Active comparator | EBUS-guided CBs of mediastinal/hilar lymph nodes will be done with 3 seconds of cryoprobe freezing time ("group 3sec.") before the biopsy together with the whole EBUS bronchoscope is extracted. Receives: Device: Cryobiopsy lymphnode group 3 sec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Primary outcome measure is diagnostic yield according to the ATS consensus 2024 of EBUS-guided CB using two different freezing times (3sec./6.sec.).
Measured: from date of randomization to the time of the first documented results, assessed up to 100 weeks
Secondary outcomes (4)
overall rate of suitability for histopathological examination
Measured: from the date of randomization to the time of the first documented results, assessed up to 100 weeks
the size of the harvested tissue (mm2)
Measured: from date of randomization to the time of the first documented results, assessed up to 100 months
), isolated and cumulative diagnostic yield of the first, second, third and fourth cryobiopsy
Measured: from date of randomization to the time of the first documented results, assessed up to100 weeks
time of the procedure
Measured: from the date of randomization to the time of the first documented results, assessed up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start7 Mar 2025
- Primary completion1 Apr 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Aarau Cantonal Hospital (KSA), Waid City Hospital, Zurich, Kantonsspital Winterthur KSW, Unispital Basel, Spital Uster AG, Uster, Switzerland, Clinique des Grangettes, Chêne-Bougeries, Insel Gruppe AG, University Hospital Bern, Réseau Hospitalier Neuchâtelois, University of Lausanne Hospitals, Cantonal Hospital of St. Gallen, Ospedale Regionale Bellinzona e Valli, HUG - Hôpitaux universitaires de Genève, Kantonsspital Chur, Switzerland, Hôpital du Valais
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921681
- Sponsor's protocol ID
- 2024-00885
- Status last verified
- Apr 2025
- First submitted
- 10 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fan Y, Zhang AM, Wu XL, Huang ZS, Kontogianni K, Sun K, Fu WL, Wu N, Kuebler WM, Herth FJF. Transbronchial needle aspiration combined with cryobiopsy in the diagnosis of mediastinal diseases: a multicentre, open-label, randomised trial. Lancet Respir Med. 2023 Mar;11(3):256-264. doi: 10.1016/S2213-2600(22)00392-7. Epub 2022 Oct 22.
PubMed 36279880Zhang J, Guo JR, Huang ZS, Fu WL, Wu XL, Wu N, Kuebler WM, Herth FJF, Fan Y. Transbronchial mediastinal cryobiopsy in the diagnosis of mediastinal lesions: a randomised trial. Eur Respir J. 2021 Dec 9;58(6):2100055. doi: 10.1183/13993003.00055-2021. Print 2021 Dec.
PubMed 33958432
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transbronchial EBUS-guided TBNA and Cryobiopsy of Mediastinal Lymph Nodes in Patients Nonsuspicious for Lung Cancer, Using Different Cryoprobe Freezing Times
- ClinicalTrials.gov ID
- NCT06921681
- Acronym / sponsor ID
- 2024-00885
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- EBUS, Cryobiopsy, TBNA, Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Aarau Cantonal Hospital (KSA), Waid City Hospital, Zurich, Kantonsspital Winterthur KSW, Unispital Basel, Spital Uster AG, Uster, Switzerland, Clinique des Grangettes, Chêne-Bougeries, Insel Gruppe AG, University Hospital Bern, Réseau Hospitalier Neuchâtelois, University of Lausanne Hospitals, Cantonal Hospital of St. Gallen, Ospedale Regionale Bellinzona e Valli, HUG - Hôpitaux universitaires de Genève, Kantonsspital Chur, Switzerland, Hôpital du Valais
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Apr 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.
EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information.
Detailed description
EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information. This study will analyze whether the freezing time influences the diagnostic yield in CB of mediastinal lymphadenopathies. Additionally we will evaluate the influence of the number of biopsies on the diagnostic yield.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 6 sec | Active comparator | Device: Cryobiopsy of lymph nodes group 6 secEBUS-guided CBs of mediastinal/hilar lymph nodes will be done with 6 seconds of cryoprobe freezing time ("group 6sec.") before the biopsy together with the whole EBUS bronchoscope is extracted. |
| group 3 sec | Active comparator | Device: Cryobiopsy lymphnode group 3 secEBUS-guided CBs of mediastinal/hilar lymph nodes will be done with 3 seconds of cryoprobe freezing time ("group 3sec.") before the biopsy together with the whole EBUS bronchoscope is extracted. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one mediastinal lesion or hilar 1 cm or longer in the short axis requiring diagnostic bronchoscopy
- Age between 18 and 90 years
- Written informed consent after participant's information
Key exclusion criteria (9 listed)
- Age < 18 and > 90 years
- Lacking ability to form an informed consent (including impaired judgement, communication barriers)
- Contraindication against bronchoscopy (e.g. co-morbidities)
- Mediastinal abscess or cyst
- Extraordinary blood supply of the lesion visualized by EBUS bronchoscope
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 |
|---|---|---|
| Cryobiopsy of lymph nodes group 6 secIncluded patients receive transbronchial access with EBUS needle (19, 21 or 22 gauge needle) Hereafter, three times EBUS-TBNA followed by four EBUS-guided-CBs with a 1.1mm cryoprobe will be performed. Included patients are 1:1 randomized to receive CB with cryoprobe activated for either 3 sec of freezing time (group "3sec") or 6 sec. of freezing time (group "6sec") before the biopsy together with the whole EBUS bronchoscope is extracted. The EBUS-guided CB will be conducted four times in each group. Aiming access to one lymph node if one lymph node cannot be punctured, another lymph node will be chosen. Even if tissue-extraction out of a lymph node via cryoprobe fails once to several times, overall no more than 4 attempts for cryobiopsy will be done | Device | group 6 sec |
| Cryobiopsy lymphnode group 3 secIncluded patients receive transbronchial access with EBUS needle (19, 21 or 22 gauge needle) Hereafter, three times EBUS-TBNA followed by four EBUS-guided-CBs with a 1.1mm cryoprobe will be performed. Included patients are 1:1 randomized to receive CB with cryoprobe activated for either 3 sec of freezing time (group "3sec") or 6 sec. of freezing time (group "6sec") before the biopsy together with the whole EBUS bronchoscope is extracted. The EBUS-guided CB will be conducted four times in each group. Aiming access to one lymph node if one lymph node cannot be punctured, another lymph node will be chosen. Even if tissue-extraction out of a lymph node via cryoprobe fails once to several times, overall no more than 4 attempts for cryobiopsy will be done | Device | group 3 sec |
Primary outcome
Diagnostic yield
Time frame: from date of randomization to the time of the first documented results, assessed up to 100 weeks
Primary outcome measure is diagnostic yield according to the ATS consensus 2024 of EBUS-guided CB using two different freezing times (3sec./6.sec.).
4 secondary outcomes
overall rate of suitability for histopathological examination
Time frame: from the date of randomization to the time of the first documented results, assessed up to 100 weeks
the size of the harvested tissue (mm2)
Time frame: from date of randomization to the time of the first documented results, assessed up to 100 months
), isolated and cumulative diagnostic yield of the first, second, third and fourth cryobiopsy
Time frame: from date of randomization to the time of the first documented results, assessed up to100 weeks
time of the procedure
Time frame: from the date of randomization to the time of the first documented results, assessed up to 100 weeks
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 10 Apr 2025.
- Background: PubMed 36279880Fan Y, Zhang AM, Wu XL, Huang ZS, Kontogianni K, Sun K, Fu WL, Wu N, Kuebler WM, Herth FJF. Transbronchial needle aspiration combined with cryobiopsy in the diagnosis of mediastinal diseases: a multicentre, open-label, randomised trial. Lancet Respir Med. 2023 Mar;11(3):256-264. doi: 10.1016/S2213-2600(22)00392-7. Epub 2022 Oct 22.
- Background: PubMed 33958432Zhang J, Guo JR, Huang ZS, Fu WL, Wu XL, Wu N, Kuebler WM, Herth FJF, Fan Y. Transbronchial mediastinal cryobiopsy in the diagnosis of mediastinal lesions: a randomised trial. Eur Respir J. 2021 Dec 9;58(6):2100055. doi: 10.1183/13993003.00055-2021. Print 2021 Dec.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryobiopsy of lymph nodes group 6 sec and Cryobiopsy lymphnode group 3 sec in people with Lung Cancer (NSCLC), run by University of Zurich at 1 site in Switzerland.
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 9 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 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 Carolin Steinack (0041 44 255 8689, carolin.steinack@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: from date of randomization to the time of the first documented results, assessed up to 100 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06921681, which also lists 2 linked publications.
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 10 Apr 2025.