Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 5:36 AM
Study NCT ID:
NCT04392167
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2020-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
a/LCI-OCT Pilot in Esophagus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.wax@duke.edu', 'phone': '919-660-5143', 'title': 'Dr. Adam Wax', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 week', 'description': 'Participants were contacted 1 week after a/LCI-OCT imaging to assess any adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'a/LCI-OCT Imaging of the Esophagus', 'description': 'All participants who were able to swallow the a/LCI-OCT probe had a/LCI-OCT imaging of the esophagus. These participants then also had biopsies of the esophageal tissue that was imaged by the a/LCI-OCT probe.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 22, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 20}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'throat tightness / trouble swallowing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Correctly Identified Positive (Dysplastic) Biopsies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}, {'units': 'positive biopsies', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'a/LCI-OCT Imaging of the Esophagus', 'description': 'a/LCI-OCT imaging probe: a/LCI and OCT imaging measurements of several locations in the esophagus\n\nesophageal biopsy: biopsies of esophageal tissue imaged by a/LCI-OCT probe'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 1', 'description': 'Sensitivity of the a/LCI-OCT probe to detect dysplasia as measured by percentage of correctly identified positive biopsies. The a/LCI-OCT measurement of mean nuclear size was compared with a pre-determined threshold of mean nuclear size (11.84 microns from Terry et al study) to categorize biopsy samples as dysplastic or non-dysplastic.', 'unitOfMeasure': 'percentage of correct identifications', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'positive biopsies', 'denomUnitsSelected': 'positive biopsies'}, {'type': 'PRIMARY', 'title': 'Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'negative biopsies', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'a/LCI-OCT Imaging of the Esophagus', 'description': 'All participants who were able to swallow the a/LCI-OCT probe had a/LCI-OCT imaging of the esophagus, with measurements in at least 5 locations. These participants then also had biopsies of the esophageal tissue that was imaged by the a/LCI-OCT probe.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 1', 'description': 'Specificity of the a/LCI-OCT probe to detect absence of dysplasia as measured by percentage of correctly identified negative biopsies. The a/LCI-OCT measurement of mean nuclear size was compared with a pre-determined threshold of mean nuclear size (11.84 microns from Terry et al study) to categorize biopsy samples as dysplastic or non-dysplastic.', 'unitOfMeasure': 'percentage of correct identifications', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'negative biopsies', 'denomUnitsSelected': 'negative biopsies'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adequate Tissue Contact to Acquire a High Quality Image', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'a/LCI-OCT Imaging of the Esophagus', 'description': 'All participants who were able to swallow the a/LCI-OCT probe had a/LCI-OCT imaging of the esophagus, with measurements in at least 5 locations. These participants then also had biopsies of the esophageal tissue that was imaged by the a/LCI-OCT probe.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 1', 'description': 'percentage of participants that had adequate tissue contact to acquire high quality a/LCI-OCT images', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'a/LCI-OCT Imaging of the Esophagus', 'description': 'All participants who were able to swallow the a/LCI-OCT probe had a/LCI-OCT imaging of the esophagus. These participants then also had biopsies of the esophageal tissue that was imaged by the a/LCI-OCT probe.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'unable to swallow a/LCI-OCT probe', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'a/LCI-OCT Imaging of the Esophagus', 'description': 'All participants who were able to swallow the a/LCI-OCT probe had a/LCI-OCT imaging of the esophagus. These participants then also had biopsies of the esophageal tissue that was imaged by the a/LCI-OCT probe.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '65.4', 'spread': '7.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant did not report age.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One participant did not report sex.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Stage of Barrett's Esophagus", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'categories': [{'title': "non-dysplastic Barrett's Esophagus", 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': "Barrett's Esophagus with low grade dysplasia", 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': "Barrett's Esophagus with high grade dysplasia", 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': "history of Barrett's Esophagus with CEIM (complete eradication of intestinal metaplasia)", 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': "normal asymptomatic control without history of Barrett's Esophagus", 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-14', 'size': 1364371, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-19T10:15', 'hasProtocol': True}, {'date': '2022-05-31', 'size': 372805, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-07T15:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2020-05-14', 'resultsFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-27', 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Correctly Identified Positive (Dysplastic) Biopsies', 'timeFrame': 'day 1', 'description': 'Sensitivity of the a/LCI-OCT probe to detect dysplasia as measured by percentage of correctly identified positive biopsies. The a/LCI-OCT measurement of mean nuclear size was compared with a pre-determined threshold of mean nuclear size (11.84 microns from Terry et al study) to categorize biopsy samples as dysplastic or non-dysplastic.'}, {'measure': 'Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies', 'timeFrame': 'day 1', 'description': 'Specificity of the a/LCI-OCT probe to detect absence of dysplasia as measured by percentage of correctly identified negative biopsies. The a/LCI-OCT measurement of mean nuclear size was compared with a pre-determined threshold of mean nuclear size (11.84 microns from Terry et al study) to categorize biopsy samples as dysplastic or non-dysplastic.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Adequate Tissue Contact to Acquire a High Quality Image', 'timeFrame': 'day 1', 'description': 'percentage of participants that had adequate tissue contact to acquire high quality a/LCI-OCT images'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Barrett Esophagus']}, 'referencesModule': {'references': [{'pmid': '20854820', 'type': 'BACKGROUND', 'citation': "Terry NG, Zhu Y, Rinehart MT, Brown WJ, Gebhart SC, Bright S, Carretta E, Ziefle CG, Panjehpour M, Galanko J, Madanick RD, Dellon ES, Trembath D, Bennett A, Goldblum JR, Overholt BF, Woosley JT, Shaheen NJ, Wax A. Detection of dysplasia in Barrett's esophagus with in vivo depth-resolved nuclear morphology measurements. Gastroenterology. 2011 Jan;140(1):42-50. doi: 10.1053/j.gastro.2010.09.008. Epub 2010 Sep 18."}]}, 'descriptionModule': {'briefSummary': "This study will test a newly developed dual modality probe, including optical coherence tomography (OCT) and angle-resolved low-coherence interferometry (a/LCI), in the human esophagus to determine 1) whether adequate tissue contact can be attained by the probe to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium. This pilot study will test the operating characteristics of the probe and collect data for further optimization of the a/LCI-OCT device."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presenting to University of North Carolina (UNC) for routine care upper endoscopy\n* Meet one of the following criteria:\n\n 1. Current dysplastic or non-dysplastic Barrett's Esophagus of any length OR,\n 2. History of dysplastic or non-dysplastic Barrett's Esophagus after treatment with endoscopic eradication therapy (EET) OR,\n 3. Normal asymptomatic controls without any history of dysplastic Barrett's Esophagus\n* Aged 18 to 80\n* Able to read, comprehend, and understand the informed consent document\n\nExclusion Criteria:\n\n* Prior esophageal surgery (uncomplicated nissen fundoplication OK)\n* Pregnant women\n* Unable to provide written informed consent"}, 'identificationModule': {'nctId': 'NCT04392167', 'briefTitle': 'a/LCI-OCT Pilot in Esophagus', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An a/LCI-Optical Coherence Tomography (OCT) Pilot Study', 'orgStudyIdInfo': {'id': 'Pro00090173_1'}, 'secondaryIdInfos': [{'id': 'R01CA210544', 'link': 'https://reporter.nih.gov/quickSearch/R01CA210544', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'a/LCI-OCT Imaging of the Esophagus', 'interventionNames': ['Device: a/LCI-OCT imaging probe', 'Procedure: esophageal biopsy']}], 'interventions': [{'name': 'a/LCI-OCT imaging probe', 'type': 'DEVICE', 'description': 'a/LCI and OCT imaging measurements of several locations in the esophagus', 'armGroupLabels': ['a/LCI-OCT Imaging of the Esophagus']}, {'name': 'esophageal biopsy', 'type': 'PROCEDURE', 'description': 'biopsies of esophageal tissue imaged by a/LCI-OCT probe', 'armGroupLabels': ['a/LCI-OCT Imaging of the Esophagus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Adam Wax, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}