Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-03 @ 3:06 PM
Study NCT ID:
NCT04153318
Status:
UNKNOWN
Last Update Posted:
2019-11-06
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Efficacy of FFOCT Imaging for Tissue Sample Obtained by EUSFNB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-05', 'studyFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of Light-CT', 'timeFrame': '1week after procedure', 'description': 'The true positive rate measures the proportion of positives that are correctly identified by Light-CT'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of Light-CT', 'timeFrame': '1week after procedure', 'description': 'The true negative rate measures the proportion of positives that are correctly identified by Light-CT'}, {'measure': 'The diagnostic efficacy of Light-CT for different pancreatic diseases', 'timeFrame': '1week after procedure', 'description': 'Comparing the sensitivity and specificity of FFOCT in the diagnosis of different pancreatic diseases'}, {'measure': 'coherence of FFOCT diagnoses by assistant and pathologist', 'timeFrame': '1week after procedure', 'description': 'comparing the diagnostic coherence of FFOCT by trained assistant( endoscopist) and trained pathologist'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Diseases']}, 'descriptionModule': {'briefSummary': 'In most Asian medical centers, rapid on-site cytology evaluation is not available, the number of needle passes of EUS-FNA is decided by endoscopists. Full-field optical coherence tomography (FF-OCT) is a new optical imaging technique that could generate sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the morphological structure and pathological changes in minutes without conventional tissue preparation, slicing, and staining, and dynamic cell imaging (DCI) added the viability information of cells/tissue, which could be more important in sample rapid evaluation.', 'detailedDescription': 'Light-CT, a special-designed pathology-approximation system which is based on the lighting feature or dynamic feature of tissue and cells, is used to detect malignant cells or tissue in fresh specimens. Morphological structure and pathological changes could be captured in minutes, which implies a possible application in intraoperative diagnosis. The investigators aimed to evaluate the diagnostic efficacy of FFOCT for the tissue samples obtained from EUS-FNB of pancreas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients with pancreatic diseases who receive EUS-FNA/B with tissue sample obtained will be enrolled in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tissue samples can be obtained via EUS-FNB\n* Signed informed consent letter\n\nExclusion Criteria:\n\n* Unable or refuse to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04153318', 'briefTitle': 'Diagnostic Efficacy of FFOCT Imaging for Tissue Sample Obtained by EUSFNB', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Comparing of FFOCT Imaging for Pancreatic Tissue Sample Obtained by EUSFNB and Conventional Histological Examination', 'orgStudyIdInfo': {'id': 'FFOCT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'full-field optical coherence tomography', 'type': 'DEVICE', 'description': 'Pancreatic tissue sample obtained by EUS-FNB will be used for FFOCT imaging. The Images will be sent to trained pathologists for diagnosis. The same tissue sample will be sent to the pathology department for routine histological examination. Compare the diagnoses made by the 2 different methods.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wei Zhou, M.D.', 'role': 'CONTACT', 'email': 'zhou_wei0012@163.com', 'phone': '+8618021009362'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief of the Gastroenterology', 'investigatorFullName': 'Zhaoshen Li', 'investigatorAffiliation': 'Changhai Hospital'}}}}