Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-02-21 @ 8:31 AM
Study NCT ID:
NCT02961335
Status:
UNKNOWN
Last Update Posted:
2018-05-30
First Post:
2016-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001999', 'term': 'Bronchoscopy'}, {'id': 'D015193', 'term': 'Chorionic Villi Sampling'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D011296', 'term': 'Prenatal Diagnosis'}, {'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-25', 'studyFirstSubmitDate': '2016-11-08', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule', 'timeFrame': 'Day 1', 'description': 'Confocal imaging will be considered as "positive" when both\n\n* a solid pattern is displayed\n* a diagnostic biopsy is obtained at the site of confocal imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Parenchymal Lung Diseases']}, 'descriptionModule': {'briefSummary': 'Diffuse parenchymal lung diseases (DPLD) include a variety of respiratory conditions that affect either the pulmonary interstitium or the alveolar space . The etiological diagnosis of DPLD is often challenging, because of the large number of pathological entities involved, which share close clinical and radiological presentations. High resolution Chest CT, a key diagnostic procedure in DPLD, is subject to significant inter-observer analysis variations, so that the diagnosis sometimes requires a surgical or transbronchial lung biopsy sampling. This invasive procedure is not devoid of morbidity and may be impossible to perform in fragile patients. Therefore, the definite diagnosis of DPLD is usually achieved following a multi-disciplinary expert consensus, based on careful medical history, chest CT and bronchoalveolar lavage examinations.\n\nAlveolar probe-based confocal laser endomicroscopy (pCLE) is a mini invasive endoscopic technique that allows distal lung microscopic imaging in vivo, during a flexible bronchoscopy performed under topical anaesthesia. Since 2006, Alveolar pCLE has been used in a monocentric clinical trial at the Rouen University Hospital in more than 200 patients and healthy volunteers. This allowed the first pCLE in-vivo description of normal pulmonary acinus, and confirmed the safety of the technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18\n* signed written informed consent\n* indication for a flexible bronchoscopy\n* DPLD characterized by clinical and radiological data compatible with : idiopathic pulmonary fibrosis (IPF), acute or chronic hypersensitivity pneumonitis (HPS), sarcoidosis, or asbestosis.\n* Initial histological confirmation of the disease is not required for the inclusion of the patient and the realisation of the alveolar bronchoscopy.\n* non-smoking or smoking cessation \\>6 month\n* Patient affiliated with, or beneficiary of a social security category\n\nExclusion Criteria:\n\n* respiratory failure and contraindication for a flexible bronchoscopy (this item will stay at the appreciation of the physician, arterial blood gaz sampling being not required)\n* bleeding disorder which would be not compatible with the realization of a flexible bronchoscopy\n* history of pneumonectomy or non functional lung controlateral to the pCLE procedure\n* patients for which a per-endoscopic distal lung cryobiopsy is forecasted during the first diagnostic bronchoscopy,\n* patients for which the bronchoscopy needs a general anesthesia and mechanical ventilation during the procedure\n* anticoagulant or platelet aggregation inhibitors that cannot be interrupted for the flexible bronchoscopy\n* patients for which a follow up or an adequate work-up to achieve the final diagnosis will not be possible.\n* patients for which a cryobiopsy is forecasted during the bronchoscopy\n* pregnant and breast feeding women, or women of childbearing potential not taking adequate contraception\n* Patients unable to understand informed consent\n* Patient on major legal measure of protection\n* Patients participating in an other interventional clinical trial at the inclusion date'}, 'identificationModule': {'nctId': 'NCT02961335', 'acronym': 'Microsemio-PI', 'briefTitle': 'Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases : A Multicentric Prospective Study', 'orgStudyIdInfo': {'id': '2014/208/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient who need to undergo bronchoscopy', 'description': 'Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done', 'interventionNames': ['Procedure: Bronchoscopy', 'Procedure: Confocal microendoscopy', 'Procedure: Biopsy sampling']}], 'interventions': [{'name': 'Bronchoscopy', 'type': 'PROCEDURE', 'description': 'Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done', 'armGroupLabels': ['Patient who need to undergo bronchoscopy']}, {'name': 'Confocal microendoscopy', 'type': 'PROCEDURE', 'description': 'Confocal microendoscopy will be performed during this initial bronchoscopy', 'armGroupLabels': ['Patient who need to undergo bronchoscopy']}, {'name': 'Biopsy sampling', 'type': 'PROCEDURE', 'description': 'Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done', 'armGroupLabels': ['Patient who need to undergo bronchoscopy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rouen', 'country': 'France', 'contacts': [{'name': 'Luc THIBERVILLE, Pr', 'role': 'CONTACT', 'email': 'luc.thiberville@chu-rouen.fr'}, {'name': 'Luc THIBERVILLE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Luc THIBERVILLE, Pr', 'role': 'CONTACT', 'email': 'luc.thiverville@chu-rouen.fr'}, {'name': 'Julien BLOT', 'role': 'CONTACT', 'email': 'julien.blot@chu-rouen.fr'}], 'overallOfficials': [{'name': 'Luc THIBERVILLE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}