Endobronchial Ultrasound Strain Elastography in Sarcoidosis

Status Recruiting

Clinical 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). 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04895111
Study type	Observational
Source	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact	Rocco Trisolini, MD
Phone	+390630154204
Email	rocco.trisolini@policlinicogemelli.it
Status	Recruiting
Phase
Start date	May 10, 2021
Completion date	March 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04020380` - Azithromycin a Treatment for Pulmonary Sarcoidosis	Phase 2
Recruiting	`NCT03260556` - Pirfenidone for Progressive Fibrotic Sarcoidosis	Phase 4
Completed	`NCT05759221` - Peripheral Airway Biopsy in Sarcoidosis	N/A
Completed	`NCT03336736` - The Role of Physical Activity and Diet Within Pulmonary Sarcoidosis
Completed	`NCT03140644` - SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis	N/A
Completed	`NCT03793439` - Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis	Phase 1
Not yet recruiting	`NCT05910554` - Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis	Phase 2
Recruiting	`NCT05374447` - Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy	N/A
Active, not recruiting	`NCT04314193` - Effectiveness of Methotrexate Versus Prednisolone as First-line Therapy for Pulmonary Sarcoidosis	Phase 4
Completed	`NCT03727451` - A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis	Phase 2
Recruiting	`NCT05746039` - Feasibility of Semaglutide in Advanced Lung Disease	Phase 1/Phase 2
Completed	`NCT04803617` - Investigation of Pectoralis Muscle Strength in Elderly With Interstitial Lung Disease
Recruiting	`NCT03145922` - Epigenetic Regulation of Altered T-cell Immunity in Sarcoidosis
Completed	`NCT00279708` - Atorvastatin to Treat Pulmonary Sarcoidosis	Phase 2
Recruiting	`NCT05567133` - Risk Indicators of Sarcoidosis Evolution-Unified Protocol
Not yet recruiting	`NCT05291468` - the PHENOSAR Trial: Use of Antibiotics in Treatment of Sarcoidosis	N/A
Completed	`NCT05311150` - An RCT of NBI vs. White Light Guided Endobronchial Biopsy in Suspected Sarcoidosis	N/A
Completed	`NCT05811962` - The Diagnostic and Prognostic Role of SAA in Intrathoracic Sarcoidosis
Completed	`NCT03320070` - Acthar Gel in Participants With Pulmonary Sarcoidosis	Phase 4
Completed	`NCT03324503` - A Study to Estimate the Effect Sizes of HRCT Endpoints in Response to Glucocorticoid Induction Therapy in Subjects With Pulmonary Sarcoidosis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.