Sarcoidosis, PulmonaryNCT04895111
Endobronchial Ultrasound Strain Elastography in Sarcoidosis
An observational study of Sarcoidosis, Pulmonary, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Strain elastography (SE) is an imaging method used for the measurement of relative tissue elasticity through qualitative (color pattern) or semi-quantitative methods (strain ratio or strain histogram). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Pulmonary
- What is being tested?
- Endobronchial ultrasound strain elastography
- How many people
- 701 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2021to 31 Mar 2024
- Phase
- Observational
- 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
Study population: Patients with a clinical and radiological suspect of sarcoidosis.
Who may be able to join
- Age 18 years or older.
- ASA physical status I-III.
- Clinical/radiological (computed tomography) suspicion of sarcoidosis (Stages I to III)
Who cannot join
- Inability or unwillingness to consent.
- Severe bleeding disorders
- Contraindication for temporary interruption of the use of anticoagulant or antiplatelet therapy different from aspirin.
- Recent and/or uncontrolled cardiac disease, uncontrolled pulmonary hypertension.
- Compromised upper airway (eg, concomitant head and neck cancer or central airway stenosis for any reason).
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Fausto Leoncini, MD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Fausto Leoncini, MD, +390630154204, fausto.leoncini@policlinicogemelli.it
About this study
Official title: Role of Endobronchial Ultrasound Strain Elastography (EBUS-SE) in Sarcoidosis: a Prospective Cohort Study
Strain elastography (SE) is an imaging method used for the measurement of relative tissue elasticity through qualitative (color pattern) or semi-quantitative methods (strain ratio or strain histogram). Very recently, the first pilot study has provided preliminary evidence that EBUS-SE elastography may help identify fibrotic lymph nodes in sarcoidosis and that sampling lymph nodes characterized by low strain elastography, that is "stiff" nodes, is associated with an increased risk of retrieving an inadequate sample (i.e. a sample which is not representative of the lymph node tissue). The investigators hypothesize that an EBUS-SE pattern indicative of lymph node stiffness will be associated with less granulomas and more fibrosis.
Read the detailed description
In the last decade, the possibility to sample under ultrasound guidance (endosonography) the intrathoracic lymph nodes through the airways (endobronchial ultrasound guided, EBUS-TBNA) or through the oesophagus (endoscopic ultrasound-guided fine needle aspiration, EUS-FNA/EUS-b-FNA) has revolutionized the diagnostic approach to sarcoidosis. Individual studies and meta-analyses performed in selected and unselected patient populations have shown that EBUS and EUS both have overall diagnostic accuracy exceeding 80%. In addition, endosonography provides useful information about lymph node density; indeed, the presence of inhomogeneity in the lymph node texture on B-mode during endosonography represents the most important factor favouring infection over sarcoidosis in patients with lymphadenopathy.
Although the diagnostic success rate of EBUS-TBNA in detecting granulomas in lymph nodes of patients with suspected sarcoidosis is very high, the procedure is not foolproof and tends to have a lower yield in stages II/III as compared to stage I disease. Clinical experience suggests that at least some of the false-negative EBUS-TBNA results in sarcoidosis patients may be caused by the presence of lymph nodes with extensive fibrosis. We aim to evaluate whether EBUS-SE may help identify fibrotic lymph nodes in sarcoidosis and if the outcome of EBUS-TBNA is different in lymph nodes for which EBUS-SE suggest high fibrotic content.
- Conditions
- Sarcoidosis, Pulmonary
- Being tested
- Endobronchial ultrasound strain elastography
- Keywords
- Sarcoidosis, Endobronchial Ultrasound, Elastography, Endosonography, Granuloma
- Medical subject headings
- Sarcoidosis, Pulmonary, Sarcoidosis, Granuloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial ultrasound strain elastographyDiagnostic test
Measurement of tissue elasticity of hilar and mediastinal lymph nodes through strain elastography measured during an endonbronchial ultrasound examination
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected sarcoidosis | Consecutive patients with clinical and radiological (CT scan +/- PET) suspect of sarcoidosis Receives: Diagnostic Test: Endobronchial ultrasound strain elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Diagnostic yield for the detection of granulomas on endosonography samples according to a mean value of the strain histogram <40 or ≥40
The diagnostic yield for the detection of granulomas will be measured on a per lymph node basis (number of lymph nodes in which the pathological exam of endosonography samples identifies granulomas/number of lymph nodes submitted to endosonography)
Measured: 15 days
Secondary outcomes (2)
• Adequacy of endosonography samples according to a mean value of the strain histogram <40 or ≥40.
The adequacy will be measured on a per lymph node basis (number of lymph nodes in which the pathological exam shows an adequate endosonography sample/number of lymph nodes submitted to endosonography) and is defined as the presence of a preponderance of lymphocytes at the pathological exam of the endosonography sample.
Measured: 15 days
• Correlation between the strain elastography pattern measured with the mean value of the strain histogram and the following variables: age, sex, sarcoidosis stage (I vs II vs III), duration of sarcoidosis-related symptoms.
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 posted20 May 2021
- Study start10 May 2021
- Primary completion30 Sep 2023
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoidosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 701 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895111
- Sponsor's protocol ID
- 4066
- Status last verified
- Aug 2023
- First submitted
- 17 May 2021
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endobronchial Ultrasound Strain Elastography (EBUS-SE) in Sarcoidosis: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04895111
- Acronym / sponsor ID
- 4066
- Conditions
- Sarcoidosis, Pulmonary
- Keywords
- Sarcoidosis, Endobronchial Ultrasound, Elastography, Endosonography, Granuloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 701 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 20 May 2021 (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.
Strain elastography (SE) is an imaging method used for the measurement of relative tissue elasticity through qualitative (color pattern) or semi-quantitative methods (strain ratio or strain histogram). Very recently, the first pilot study has provided preliminary evidence that EBUS-SE elastography may help identify fibrotic lymph nodes in sarcoidosis and that sampling lymph nodes characterized by low strain elastography, that is "stiff" nodes, is associated with an increased risk of retrieving an inadequate sample (i.e. a sample which is not representative of the lymph node tissue). The investigators hypothesize that an EBUS-SE pattern indicative of lymph node stiffness will be associated with less granulomas and more fibrosis.
Detailed description
In the last decade, the possibility to sample under ultrasound guidance (endosonography) the intrathoracic lymph nodes through the airways (endobronchial ultrasound guided, EBUS-TBNA) or through the oesophagus (endoscopic ultrasound-guided fine needle aspiration, EUS-FNA/EUS-b-FNA) has revolutionized the diagnostic approach to sarcoidosis. Individual studies and meta-analyses performed in selected and unselected patient populations have shown that EBUS and EUS both have overall diagnostic accuracy exceeding 80%. In addition, endosonography provides useful information about lymph node density; indeed, the presence of inhomogeneity in the lymph node texture on B-mode during endosonography represents the most important factor favouring infection over sarcoidosis in patients with lymphadenopathy.
Although the diagnostic success rate of EBUS-TBNA in detecting granulomas in lymph nodes of patients with suspected sarcoidosis is very high, the procedure is not foolproof and tends to have a lower yield in stages II/III as compared to stage I disease. Clinical experience suggests that at least some of the false-negative EBUS-TBNA results in sarcoidosis patients may be caused by the presence of lymph nodes with extensive fibrosis. We aim to evaluate whether EBUS-SE may help identify fibrotic lymph nodes in sarcoidosis and if the outcome of EBUS-TBNA is different in lymph nodes for which EBUS-SE suggest high fibrotic content.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected sarcoidosis | – | Diagnostic Test: Endobronchial ultrasound strain elastographyConsecutive patients with clinical and radiological (CT scan +/- PET) suspect of sarcoidosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a clinical and radiological suspect of sarcoidosis.
Key inclusion criteria (3 listed)
- Age 18 years or older.
- ASA physical status I-III.
- Clinical/radiological (computed tomography) suspicion of sarcoidosis (Stages I to III)
Key exclusion criteria (6 listed)
- Inability or unwillingness to consent.
- Severe bleeding disorders
- Contraindication for temporary interruption of the use of anticoagulant or antiplatelet therapy different from aspirin.
- Recent and/or uncontrolled cardiac disease, uncontrolled pulmonary hypertension.
- Compromised upper airway (eg, concomitant head and neck cancer or central airway stenosis for any reason).
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 strain elastographyMeasurement of tissue elasticity of hilar and mediastinal lymph nodes through strain elastography measured during an endonbronchial ultrasound examination | Diagnostic test | Patients with suspected sarcoidosis |
Primary outcome
• Diagnostic yield for the detection of granulomas on endosonography samples according to a mean value of the strain histogram <40 or ≥40
Time frame: 15 days
The diagnostic yield for the detection of granulomas will be measured on a per lymph node basis (number of lymph nodes in which the pathological exam of endosonography samples identifies granulomas/number of lymph nodes submitted to endosonography)
2 secondary outcomes
• Adequacy of endosonography samples according to a mean value of the strain histogram <40 or ≥40.
Time frame: 15 days
• Correlation between the strain elastography pattern measured with the mean value of the strain histogram and the following variables: age, sex, sarcoidosis stage (I vs II vs III), duration of sarcoidosis-related symptoms.
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 27 Oct 2023.
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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.
Fausto Leoncini, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, Pulmonary, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 6 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 27 Oct 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocco Trisolini, MD (+390630154204, rocco.trisolini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Diagnostic yield for the detection of granulomas on endosonography samples according to a mean value of the strain histogram <40 or ≥40 (time frame: 15 days). 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 Oct 2023.