Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT01699867
Status:
COMPLETED
Last Update Posted:
2015-01-06
First Post:
2012-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ljacob14@jhmi.edu', 'phone': '410-502-0880', 'title': 'Lisa K. Jacobs, M.D.', 'organization': 'Johns Hopkins Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the surgical procedure.', 'description': 'The investigational device only contacted excised patient tissue. The device did not contact patients as part of this study.', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients (Single-arm)', 'description': 'All enrolled study patients.', 'otherNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patients With All Positive Margins Correctly Identified With the Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Optical Coherence Tomography (Single-arm)', 'description': 'Specimens from all patients were evaluated by optical coherence tomography.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one week after surgery', 'description': 'In this study, a patient had "positive margins" if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, "tumor on ink").', 'unitOfMeasure': 'Patients w/ all positives identified', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with positive margins (0 mm, "tumor on ink").'}, {'type': 'PRIMARY', 'title': 'Number of Margins With False Positive Device Readings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Optical Coherence Tomography (Single-arm)', 'description': 'Specimens from all patients were evaluated by optical coherence tomography.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.32', 'spread': '1.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one week after surgery', 'unitOfMeasure': 'False positive margins per patient', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with all negative margins (≥ 2 mm). On average, 5 out of 6 possible margins were analyzed per patient.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Optical Coherence Tomography (Single-arm)', 'description': 'Specimens from all patients were evaluated by optical coherence tomography.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Screening Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Optical Coherence Tomography (Single-arm)', 'description': 'Specimens from all patients were evaluated by optical coherence tomography.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '47 patients completed the study. 1 patient was excluded from the analysis due to insufficient images in all specimens (did not meet protocol specifications).'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-12', 'studyFirstSubmitDate': '2012-10-02', 'resultsFirstSubmitDate': '2014-12-05', 'studyFirstSubmitQcDate': '2012-10-02', 'lastUpdatePostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-05', 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients With All Positive Margins Correctly Identified With the Device', 'timeFrame': 'one week after surgery', 'description': 'In this study, a patient had "positive margins" if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, "tumor on ink").'}, {'measure': 'Number of Margins With False Positive Device Readings', 'timeFrame': 'one week after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lumpectomy', 'breast cancer', 'optical coherence tomography', 'tumor margin', 'imaging'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with breast cancer undergoing lumpectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women 18 years of age or older\n2. Signed informed consent form\n3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery\n4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure\n\nExclusion Criteria:\n\n1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)\n2. Neoadjuvant systemic therapy\n3. All T4 tumors\n4. Previous radiation in the operated breast\n5. Prior surgical procedure in the same quadrant\n6. Implants in the operated breast\n7. Pregnancy\n8. Lactation\n9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study'}, 'identificationModule': {'nctId': 'NCT01699867', 'briefTitle': 'Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Diagnostic Photonics, Inc.'}, 'officialTitle': 'Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)', 'orgStudyIdInfo': {'id': 'DxP 2012-02 (Part A)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Optical coherence tomography', 'type': 'DEVICE', 'description': 'Optical coherence tomography was used to image ex vivo breast tissue specimens.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Anne Arundel Medical Center', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Lisa K Jacobs, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diagnostic Photonics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}