Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT01770405
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2013-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010181', 'term': 'Pancreatic Cyst'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'C538110', 'term': 'Pancreatic adenoma'}, {'id': 'D007516', 'term': 'Adenoma, Islet Cell'}, {'id': 'D000072281', 'term': 'Lymphadenopathy'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D054119', 'term': 'Arachnodactyly'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061765', 'term': 'Endoscopic Ultrasound-Guided Fine Needle Aspiration'}], 'ancestors': [{'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}, {'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D061705', 'term': 'Image-Guided Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D018084', 'term': 'Ultrasonography, Interventional'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2013-01-10', 'studyFirstSubmitQcDate': '2013-01-15', 'lastUpdatePostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'performance evaluation', 'timeFrame': 'up to one year', 'description': '* Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (accuracy evaluation)\n* Define/Validate descriptive criteria for nCLE sequences in the characterization of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (image interpretation criteria definition'}], 'secondaryOutcomes': [{'measure': 'Safety and feasibility evaluation', 'timeFrame': 'up to one month following the procedure', 'description': '* Evaluate the feasibility and safety of nCLE for the characterization of masses and cystic tumors of the pan-creas, lymph nodes, submucosal lesions of the GI tract (IE. number of patients with complications, number of adverse events)\n* Build an atlas of images of nCLE sequences of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endomicroscopy', 'needle-based', 'pancreatic', 'cyst', 'mass', 'EUSFNA'], 'conditions': ['Pancreatic Cyst', 'Pancreatic Neoplasms', 'Pancreatic Adenoma', 'Pancreatic Cancer', 'Pancreatic Islet Cell Tumors', 'Lymph Node Mass', 'Lymphadenopathy', 'GIST']}, 'descriptionModule': {'briefSummary': 'This study focuses on four different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract, pancreatic masses and GIST tumors.\n\nOn one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses, Lymph nodes and GIST are less developed.\n\nthe objectives of the study are to\n\n* Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract\n* Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of the pancreas, lymph nodes, submucosal lesions of the GI tract', 'detailedDescription': 'The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI or respiratory tracts by means of a miniprobe inserted through an endoscopic needle. The fundamental technology, as well as the principle of operation of nCLE, is substantially similar to pCLE.\n\nendoscopic fine needles are used during EUS-FNA procedures to puncture solid organs such as the pancreas, in order to get tissue or fluid for diagnostic purposes. There are different calibers of endoscopic nee-dles used. The most commonly used calibers for EUS-FNA procedures are 22G, 19G, and 25G needles. The nCLE Confocal Miniprobe is compatible with the 19G-type needle only. It is expected to help to differentiate the different types of lesions, especially for cysts, leading to better patient management. Microscopic tissue information in real-time in vivo during an EUS-FNA procedure may allow better differentiation between mucinous and non-mucinous cysts for instance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Referral patients with a clinical indication for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract coming in for first EUS-FNA procedure at referral institution will be approached for possible inclusion into this registry', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Male or female \\> 18 years of age\n* Patient indicated for a first EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submu-cosal lesions of the GI tract\n* Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract\n* Patient with known masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract\n* For pancreatic cyst patient, suffering chronic calcifying pancreatitis\n* For pancreatic mass patient, any size or location\n* For lymph node patient, any node reachable with EUS-FNA\n* Willing and able to comply with study procedures and provide written informed consent to participate in the registry\n\nExclusion Criteria:\n\n* \\- Subjects for whom EUS-FNA procedures are contraindicated\n* Known allergy to fluorescein contrast\n* If female, breast feeding or pregnant based on a positive hCG serum or an in vitro diagnostic test result\n* Subject with multiple cysts\n* Cysts \\<20 mm in diameter\n* Previous EUS-FNA procedure performed less than 3 months ago\n* If several pancreatic masses, only one will be imaged during the nCLE procedure\n* Lymph nodes \\<5 mm in diameter\n* If several suspicious lymph nodes, only the most suspect will be imaged during the nCLE proce-dure'}, 'identificationModule': {'nctId': 'NCT01770405', 'acronym': 'US-nCLE', 'briefTitle': 'Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mauna Kea Technologies'}, 'officialTitle': 'Registry Trial for Clinical Evaluation of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract', 'orgStudyIdInfo': {'id': 'MKT_2012_nCLE_03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pancreatic cysts', 'description': 'Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst,', 'interventionNames': ['Device: Endoscopic ultrasound fine needle aspiration']}], 'interventions': [{'name': 'Endoscopic ultrasound fine needle aspiration', 'type': 'DEVICE', 'otherNames': ['ultrasonographic endoscopy', 'EUS-guided FNA'], 'description': 'Device: nCLE needle-based Confocal Laser Endomicroscopy', 'armGroupLabels': ['pancreatic cysts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore-LIJ Health System', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Divyesh V Sejpal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mauna Kea Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}