Lung NoduleNCT06123312
Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions
A study testing Tri-modality biopsy in people with Lung Nodule, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
As the former radial probe endobronchial ultrasound (RP-EBUS) guided transbronchial forceps biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique that combines forceps biopsy, needle aspiration, and transbronchial cryobiopsy in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Nodule
- What is being tested?
- Tri-modality biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2023to 4 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
- Age ≥ 18
- Written informed consent after participant's information
Who cannot join
- Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
- Pure GGO lesion
- Patients at increased risk of bleeding
- Cannot stop agents such as antiplatelet agent or anticoagulant therapy
- Coagulopathy: Thrombocytopenia (< 100,000/mm3) or prolonged PT (INR > 1.5)
- Patient with existing or risk of pulmonary and cardiovascular decompensation
Show all 9Show fewer
- Intolerance to sedation
- Vulnerable groups such as pregnant woman, breast feeding, etc.
- Previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions- A Prospective Observational Pilot Study
As the former radial probe endobronchial ultrasound (RP-EBUS) guided transbronchial forceps biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique that combines forceps biopsy, needle aspiration, and transbronchial cryobiopsy in patients with peripheral pulmonary nodules.
Read the detailed description
This is a prospective, single-arm, open-label trial designed to assess the diagnostic accuracy and safety of the Tri-modality (forceps biopsy, needle aspiration, and transbronchial cryobiopsy) biopsy in patients with peripheral pulmonary nodules.
- Conditions
- Lung Nodule
- Being tested
- Tri-modality biopsy
- Keywords
- Radial Probe Endobronchial Ultrasound, Pulmonary Nodule, Forceps Biopsy, Needle Aspiration, Cryobiopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-modality biopsyDiagnostic test
When the lung nodule is visualized by ultrathin bronchoscope (3mm) with RP-EBUS, Tri-modality biopsy is performed.
| Study group | Role | What they receive |
|---|---|---|
| Single intervention arm: Tri-modality biopsy | Experimental | Patients enrolled in this single arm will have lung nodules biopsied by Tri-modality (forceps biopsy, needle aspiration, and cryobiopsy) Receives: Diagnostic Test: Tri-modality biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield based on pathologic diagnosis
Diagnostic yield based on pathologic diagnosis is defined as percentage of definitive pathological diagnosis by transbronchial Tri-modality biopsy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of additional procedures such as repeated bronchoscopic biopsy, percutaneous needle aspiration, surgical biopsy, or CT follow-up without any invasive procedure.
Measured: Time Frame: up to 6 months
Secondary outcomes (2)
Diagnostic yield based on clinical diagnosis
Diagnostic yield based on clinical diagnosis is defined as percentage of pathological diagnosis with suspicious results by transbronchial Tri-modality biopsy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of additional procedures such as repeated bronchoscopic biopsy, percutaneous needle aspiration, surgical biopsy, or CT follow-up without any invasive procedure.
Measured: Time Frame: up to 6 months
Adverse events
Occurrence of bleeding, pneumothorax, and infection events (during the procedure and within 1 week after the intervention). Bleeding will be assessed as the following scale (a. mild = self-limiting bleeding, manageable with suction alone and without the need for any specific intervention; b. moderate = use of any additional intervention such as instillation of ice-cold saline or vasoconstrictive drugs, or transient balloon tamponade, ; c. severe = additional prolonged monitoring or intensive care therapy after the procedure or if the bleeding was fatal). Pneumothorax will be assessed as the following scale (a. pneumothorax not requiring chest tube insertion; b. pneumothorax requiring chest tube insertion).
Measured: Time Frame: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Jan 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NoduleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe-med
- Responsible party
- Sponsor
- Investigators
- Jung Seop Eom, MD, PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123312
- Sponsor's protocol ID
- 2310-020-132
- Status last verified
- Dec 2024
- First submitted
- 3 Nov 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions- A Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT06123312
- Acronym / sponsor ID
- 2310-020-132
- Conditions
- Lung Nodule
- Keywords
- Radial Probe Endobronchial Ultrasound, Pulmonary Nodule, Forceps Biopsy, Needle Aspiration, Cryobiopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Collaborators
- Erbe-med
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 8 Nov 2023 (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.
As the former radial probe endobronchial ultrasound (RP-EBUS) guided transbronchial forceps biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique that combines forceps biopsy, needle aspiration, and transbronchial cryobiopsy in patients with peripheral pulmonary nodules.
Detailed description
This is a prospective, single-arm, open-label trial designed to assess the diagnostic accuracy and safety of the Tri-modality (forceps biopsy, needle aspiration, and transbronchial cryobiopsy) biopsy in patients with peripheral pulmonary nodules.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single intervention arm: Tri-modality biopsy | Experimental | Diagnostic Test: Tri-modality biopsyPatients enrolled in this single arm will have lung nodules biopsied by Tri-modality (forceps biopsy, needle aspiration, and cryobiopsy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
- Age ≥ 18
- Written informed consent after participant's information
Key exclusion criteria (9 listed)
- Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
- Pure GGO lesion
- Patients at increased risk of bleeding
- Patient with existing or risk of pulmonary and cardiovascular decompensation
- Intolerance to sedation
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 |
|---|---|---|
| Tri-modality biopsyWhen the lung nodule is visualized by ultrathin bronchoscope (3mm) with RP-EBUS, Tri-modality biopsy is performed. | Diagnostic test | Single intervention arm: Tri-modality biopsy |
Primary outcome
Diagnostic yield based on pathologic diagnosis
Time frame: Time Frame: up to 6 months
Diagnostic yield based on pathologic diagnosis is defined as percentage of definitive pathological diagnosis by transbronchial Tri-modality biopsy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of additional procedures such as repeated bronchoscopic biopsy, percutaneous needle aspiration, surgical biopsy, or CT follow-up without any invasive procedure.
2 secondary outcomes
Diagnostic yield based on clinical diagnosis
Time frame: Time Frame: up to 6 months
Adverse events
Time frame: Time Frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jung Seop Eom, MD, PhD principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tri-modality biopsy in people with Lung Nodule, run by Pusan National University Hospital at 1 site in South Korea.
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: finished, as of the sponsor's last update on 27 Dec 2024. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield based on pathologic diagnosis (time frame: Time Frame: up to 6 months). 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 27 Dec 2024.