Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-21 @ 11:01 AM
Study NCT ID:
NCT03842358
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'debbie.bennett@wustl.edu', 'phone': '314-454-7696', 'title': 'Debbie Bennett, M.D.', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events that occurred within 24 hours of an NIR/US exam were collected. All-cause mortality was collected through 24 hours of the NIR/US exam.', 'description': 'The protocol states that there are two phases: phase I - training set \\& phase 2 - prospective trial. For the training set, the readers underwent a training session using a tool created from a pre-existing DOT findings in patients who had previously undergone US-guided DOT and who had a spectrum of documented benign and malignant pathology. Those patients were not consented or enrolled in this study and are not included in the data.\n\nNon-serious adverse events were not collected for the patients.', 'eventGroups': [{'id': 'EG000', 'title': 'US-DOT (US/NIR) Imaging', 'description': '* US-DOT (US/NIR) Imaging Exam\n* Breast biopsy or FNA performed (standard of care)\n* A hand-held hybrid probe will be used for the scans', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 286, 'otherNumAffected': 0, 'seriousNumAtRisk': 286, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Impact of US-guided DOT on the Potential Reduction of Benign Biopsies as Measured by Comparing the Reads With a Non- Suspicious Assessment of Conventional Imaging (CI) Alone Versus CI & US-DOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}, {'units': 'BIRADS assessments', 'counts': [{'value': '628', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'US-DOT (US/NIR) Imaging', 'description': '* US-DOT (US/NIR) Imaging Exam\n* Breast biopsy or FNA performed (standard of care)\n* A hand-held hybrid probe will be used for the scans'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient', 'description': "-BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. Benign biopsy reduction will be calculated as the proportion of reads (CI \\& US-DOT subtract CI) with a non- suspicious assessment, i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', divided by the denominator of total reads with no cancer demonstrated at biopsy. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist.", 'unitOfMeasure': 'BIRADS assessments', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BIRADS assessments', 'denomUnitsSelected': 'BIRADS assessments'}, {'type': 'PRIMARY', 'title': 'Impact of US-guided DOT as an Adjunct to Conventional Breast Imaging on Maintaining High Sensitivity as Measured by Comparing the False Negative Rate or Missing Malignancy of Conventional Imaging (CI=US +/- Mammography) Alone Versus CI & US-DOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}, {'units': 'BIRADS assessments', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'US-DOT (US/NIR) Imaging', 'description': '* US-DOT (US/NIR) Imaging Exam\n* Breast biopsy or FNA performed (standard of care)\n* A hand-held hybrid probe will be used for the scans'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient', 'description': "-BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. The engineering team is also blinded to the biopsy exam and pathology outcomes. The False Negative Rate will be calculated as the proportion of reads with a non-suspicious assessment i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', who have cancer (defined as Invasive cancer or Ductal Carcinoma In Situ) demonstrated at biopsy divided by the denominator of all reads with cancer. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist.", 'unitOfMeasure': 'BIRADS assessments', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BIRADS assessments', 'denomUnitsSelected': 'BIRADS assessments'}, {'type': 'PRIMARY', 'title': 'Assess the Impact of Adjunctive US-guided DOT Data in the Management of Discordant Pathology Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'US-DOT (US/NIR) Imaging', 'description': '* US-DOT (US/NIR) Imaging Exam\n* Breast biopsy or FNA performed (standard of care)\n* A hand-held hybrid probe will be used for the scans'}], 'timeFrame': 'Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient', 'reportingStatus': 'POSTED', 'populationDescription': 'There were not any cases that were considered discordant in clinical practice as such there was not any data to present for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'US-DOT (US/NIR) Imaging', 'description': '* US-DOT (US/NIR) Imaging Exam\n* Breast biopsy or FNA performed (standard of care)\n* A hand-held hybrid probe will be used for the scans'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '286'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Poor DOT probe contact with breast', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'DOT system problem', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Switched to x-ray guided biopsy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'No biopsy after physician review', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Patient withdrew', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'The protocol states that there are two phases: phase I - training set and phase 2 - prospective trial. For the training set, the readers underwent an approximately 60-minute training session using a tool created from a pre-existing representative DOT findings in patients who had previously undergone US-guided DOT and who had a spectrum of documented benign and malignant pathology. Those patients were not consented or enrolled in this study and are not included in the presented data.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'US-DOT (US/NIR) Imaging', 'description': '* US-DOT (US/NIR) Imaging Exam\n* Breast biopsy or FNA performed (standard of care)\n* A hand-held hybrid probe will be used for the scans'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '298', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '287', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '86', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '201', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '298', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The protocol states that there are two phases: phase I - training set and phase 2 - prospective trial. For the training set, the readers underwent an approximately 60-minute training session using a tool created from a pre-existing representative DOT findings in patients who had previously undergone US-guided DOT and who had a spectrum of documented benign and malignant pathology. Those patients were not consented or enrolled in this study and are not included in the presented data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-30', 'size': 995995, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-22T11:21', 'hasProtocol': True}, {'date': '2024-11-13', 'size': 303534, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-20T09:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2019-01-29', 'resultsFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2019-02-12', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-05', 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of US-guided DOT on the Potential Reduction of Benign Biopsies as Measured by Comparing the Reads With a Non- Suspicious Assessment of Conventional Imaging (CI) Alone Versus CI & US-DOT', 'timeFrame': 'Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient', 'description': "-BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. Benign biopsy reduction will be calculated as the proportion of reads (CI \\& US-DOT subtract CI) with a non- suspicious assessment, i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', divided by the denominator of total reads with no cancer demonstrated at biopsy. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist."}, {'measure': 'Impact of US-guided DOT as an Adjunct to Conventional Breast Imaging on Maintaining High Sensitivity as Measured by Comparing the False Negative Rate or Missing Malignancy of Conventional Imaging (CI=US +/- Mammography) Alone Versus CI & US-DOT', 'timeFrame': 'Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient', 'description': "-BI-RADS scores without and then with optical data will be rendered by study radiologists. Radiologists will be blinded to the biopsy exam and pathology outcomes. Optical data including total Hemoglobin concentration will be provided by the bioengineering team. The engineering team is also blinded to the biopsy exam and pathology outcomes. The False Negative Rate will be calculated as the proportion of reads with a non-suspicious assessment i.e. BIRADS 2 'benign' or BIRADS 3 'probably benign', who have cancer (defined as Invasive cancer or Ductal Carcinoma In Situ) demonstrated at biopsy divided by the denominator of all reads with cancer. US-guided core biopsy results and subsequent surgical pathology (if present) will be entered by the study pathologist."}, {'measure': 'Assess the Impact of Adjunctive US-guided DOT Data in the Management of Discordant Pathology Results', 'timeFrame': 'Completion of enrollment for all patients (61 months), the imaging session took approximately 1 hour for the participating patient'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Biopsy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'Ultrasound-guided diffuse optical tomography (DOT) has demonstrated its potential role in differentiating malignant and benign breast abnormalities and in predicting and monitoring the neoadjuvant chemotherapy (NAC) response of breast cancer. This unique approach employs a commercial ultrasound (US) transducer and near infrared (NIR) optical imaging sensors mounted on a hand-held US probe. The co-registered US is used for lesion localization, and optical sensors are used for imaging tumor related vascularity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects ≥ 18 years old with ultrasound visible breast abnormalities (BI-RADS 3\\*, 4A, 4B, 4C, and 5) referred for ultrasound-guided core needle biopsy or fine needle aspiration\n\n \\*note that while a BI-RADS 3 assessment is probably benign, a subset of patients with this assessment choose to undergo biopsy rather than follow up imaging).\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Lesions located in the darkly pigmented nipple-areolar complex area\n* Subjects with breast implants\n* Abnormality in the mirror image location of the contralateral breast.\n* Additional abnormalities in the same region of the breast that would be included in US-guided DOT imaging of the abnormality undergoing biopsy\n* Previous breast irradiation of the mirror image location of the contralateral breast\n* Lesions located at previous biopsy sites when biopsy occurred within the last six months.\n* Pregnancy\n* Superficial abnormalities located entirely within (i.e. less than) 5mm of the overlying skin'}, 'identificationModule': {'nctId': 'NCT03842358', 'briefTitle': 'Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Improving Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography', 'orgStudyIdInfo': {'id': '201707042'}, 'secondaryIdInfos': [{'id': '1R01CA228047-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA228047-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'US-DOT (US/NIR) Imaging', 'description': '* US-DOT (US/NIR) Imaging Exam\n* Breast biopsy or FNA performed (standard of care)\n* A hand-held hybrid probe will be used for the scans', 'interventionNames': ['Device: Hand-held hybrid probe']}], 'interventions': [{'name': 'Hand-held hybrid probe', 'type': 'DEVICE', 'description': 'Consists of a commercially available US transducer located in the middle and near-infrared source and detector optical fibers distributed at the periphery', 'armGroupLabels': ['US-DOT (US/NIR) Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Debbie Bennett, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}