Endobronchial MassEBUS-CRYONCT06250387
Prospective Feasibility Study of Endobronchial Ultrasound Transbronchial Cryobiopsy (EBUS-TBCB 1.1 mm Probe) Among Patients With Mediastinal Lymphadenopathies
A study testing Endobronchial ultrasound transbronchial cryobiopsy in people with Endobronchial Mass, run by Fondation Hôpital Saint-Joseph.
Trial summary
Mediastinal lymph nodes enlargement with short axis diameter >15 mm is conventionally defined as a mediastinal lymphadenopathy. The causes of mediastinal lymphadenopathy can be malignant or benign, (infectious, inflammatory, and other such as drug toxicity). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endobronchial Mass
- What is being tested?
- Endobronchial ultrasound transbronchial cryobiopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Sep 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 ≥ 18 years of age
- Mediastinal and/or hilar lymphadenopathies > 20 mm on an injected chest CT scan
- Suspicion of lymphoproliferative disease, sarcoidosis or tuberculosis
- Hypermetabolism of mediastinal and/or hilar lymphadenopathies on PET scan (SUV max > 3)
- No contraindication for general anesthesia
- French-speaking Patient
- -Signed informed consent
Who cannot join
- Patient not covered by the French social security system
- Patient with legal protection
- Pregnant or breastfeeding patient (if applicable)
- Patient under guardianship or curatorship
- Patient deprived of liberty
Trial locations and contacts
No sites are listed yet.
About this study
Mediastinal lymph nodes enlargement with short axis diameter >15 mm is conventionally defined as a mediastinal lymphadenopathy. The causes of mediastinal lymphadenopathy can be malignant or benign, (infectious, inflammatory, and other such as drug toxicity).
- Conditions
- Endobronchial Mass
- Being tested
- Endobronchial ultrasound transbronchial cryobiopsy
- Keywords
- Patients with mediastinal lymphadenopathies.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial ultrasound transbronchial cryobiopsyProcedure or surgery
Also called Endobronchial ultrasound transbronchial cryobiopsy (EBUS-TBCB 1.1 mm probe) among patients with mediastinal lymphadenopathies.
Endobronchial Ultrasound (EBUS) :
EBUS is usually performed under general anesthesia using a laryngeal masque. It has a linear ultrasonography with a 7.5 MHz frequency. The distal part of the endoscope contains a water filled balloon used as a liquid interface, camera, light source and a working channel. The needle is protected by a sheath to prevent working channel damage. The endoscope is connected to a processor that reflects both endobronchial and ultrasound images on a screen.
EBUS - TBNA : EBUS - Transbronchial needle aspiration EBUS - TBCB: EBUS - Transbronchial Cryo Biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patients with mediastinal lymphadenopathy | Experimental | Patients with suspicion of lymphoma, sarcoidosis and tuberculosis, presenting with mediastinal lymphadenopathy confirmed by a CT scan and/ or PET scan and patients with previous negative EBUS-TBNA. Receives: Procedure: Endobronchial ultrasound transbronchial cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility of EBUS TBCB 1.1 mm probe.
Number of successes of the procedure. A success is defined by the ability to perform a biopsy.
Measured: 6 Months
Secondary outcomes (4)
To estimate the sensitivity of EBUS TBCB probe 1.1 mm in the diagnosis of mediastinal lymphadenopathy.
anapathology analysis
Measured: 7 Months
To estimate the specificity of EBUS TBCB probe 1.1 mm in the diagnosis of mediastinal lymphadenopathy.
Measured: 7 Months
To estimate the procedure time.
The procedure time is defined by the time elapsed between introduction and removal of the EBUS probe
Measured: Day 0
To assess the post-procedure complications rate.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (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 Endobronchial MassStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250387
- Sponsor's protocol ID
- 2023-A00969-36
- Acronym
- EBUS-CRYO
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ernst A, Anantham D, Eberhardt R, Krasnik M, Herth FJ. Diagnosis of mediastinal adenopathy-real-time endobronchial ultrasound guided needle aspiration versus mediastinoscopy. J Thorac Oncol. 2008 Jun;3(6):577-82. doi: 10.1097/JTO.0b013e3181753b5e.
PubMed 18520794Silvestri GA, Gonzalez AV, Jantz MA, Margolis ML, Gould MK, Tanoue LT, Harris LJ, Detterbeck FC. Methods for staging non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e211S-e250S. doi: 10.1378/chest.12-2355.
PubMed 23649440
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Feasibility Study of Endobronchial Ultrasound Transbronchial Cryobiopsy (EBUS-TBCB 1.1 mm Probe) Among Patients With Mediastinal Lymphadenopathies
- ClinicalTrials.gov ID
- NCT06250387
- Acronym / sponsor ID
- EBUS-CRYO / 2023-A00969-36
- Conditions
- Endobronchial Mass
- Keywords
- Patients with mediastinal lymphadenopathies.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 9 Feb 2024 (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.
Mediastinal lymph nodes enlargement with short axis diameter >15 mm is conventionally defined as a mediastinal lymphadenopathy. The causes of mediastinal lymphadenopathy can be malignant or benign, (infectious, inflammatory, and other such as drug toxicity).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with mediastinal lymphadenopathy | Experimental | Procedure: Endobronchial ultrasound transbronchial cryobiopsyPatients with suspicion of lymphoma, sarcoidosis and tuberculosis, presenting with mediastinal lymphadenopathy confirmed by a CT scan and/ or PET scan and patients with previous negative EBUS-TBNA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient ≥ 18 years of age
- Mediastinal and/or hilar lymphadenopathies > 20 mm on an injected chest CT scan
- Suspicion of lymphoproliferative disease, sarcoidosis or tuberculosis
- Hypermetabolism of mediastinal and/or hilar lymphadenopathies on PET scan (SUV max > 3)
- No contraindication for general anesthesia
Key exclusion criteria (5 listed)
- Patient not covered by the French social security system
- Patient with legal protection
- Pregnant or breastfeeding patient (if applicable)
- Patient under guardianship or curatorship
- Patient deprived of liberty
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 |
|---|---|---|
| Endobronchial ultrasound transbronchial cryobiopsyAlso: Endobronchial ultrasound transbronchial cryobiopsy (EBUS-TBCB 1.1 mm probe) among patients with mediastinal lymphadenopathies.Endobronchial Ultrasound (EBUS) : EBUS is usually performed under general anesthesia using a laryngeal masque. It has a linear ultrasonography with a 7.5 MHz frequency. The distal part of the endoscope contains a water filled balloon used as a liquid interface, camera, light source and a working channel. The needle is protected by a sheath to prevent working channel damage. The endoscope is connected to a processor that reflects both endobronchial and ultrasound images on a screen. EBUS - TBNA : EBUS - Transbronchial needle aspiration EBUS - TBCB: EBUS - Transbronchial Cryo Biopsy | Procedure or surgery | Patients with mediastinal lymphadenopathy |
Primary outcome
To evaluate the feasibility of EBUS TBCB 1.1 mm probe.
Time frame: 6 Months
Number of successes of the procedure. A success is defined by the ability to perform a biopsy.
4 secondary outcomes
To estimate the sensitivity of EBUS TBCB probe 1.1 mm in the diagnosis of mediastinal lymphadenopathy.
Time frame: 7 Months
To estimate the specificity of EBUS TBCB probe 1.1 mm in the diagnosis of mediastinal lymphadenopathy.
Time frame: 7 Months
To estimate the procedure time.
Time frame: Day 0
To assess the post-procedure complications rate.
Time frame: 1 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 18520794Ernst A, Anantham D, Eberhardt R, Krasnik M, Herth FJ. Diagnosis of mediastinal adenopathy-real-time endobronchial ultrasound guided needle aspiration versus mediastinoscopy. J Thorac Oncol. 2008 Jun;3(6):577-82. doi: 10.1097/JTO.0b013e3181753b5e.
- Background: PubMed 23649440Silvestri GA, Gonzalez AV, Jantz MA, Margolis ML, Gould MK, Tanoue LT, Harris LJ, Detterbeck FC. Methods for staging non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e211S-e250S. doi: 10.1378/chest.12-2355.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial ultrasound transbronchial cryobiopsy in people with Endobronchial Mass, run by Fondation Hôpital Saint-Joseph.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir HANNA (+33140942456, a.hanna@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility of EBUS TBCB 1.1 mm probe. (time frame: 6 Months). 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 NCT06250387, 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 9 Feb 2024.