Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05757427
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2023-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'luc.duchesne91@gmail.com', 'phone': '+33 (0) 6 70 33 91 20', 'title': 'Luc Duchesne', 'organization': 'MVG Industries SAS'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '21 days', 'description': 'Adverse Events and Adverse Device Effects were recorded from patient consent until the End of Study Follow Up Visit (up to 21 days post MWBI or prior to surgery, whichever happened first). Comprehensive assessments of any adverse event/device experienced by the subject was performed throughout the course of the study. Adverse events which occurred in Users or Other Persons (not study subjects) were also collected throughout the study along with device deficiencies', 'eventGroups': [{'id': 'EG000', 'title': 'Wavelia MWBI scan', 'description': 'Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 4, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Immune system disorders', 'notes': 'Allergic contact dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 27.0'}, {'term': 'Musculoskeletal and connective tissue disorders', 'notes': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 27.0'}, {'term': 'General disorders and administration site conditions', 'notes': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 27.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assess the Detectability Rate of Malignant and Benign Breast Lesions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}, {'units': 'Dominant Lesions - Malignant & Benign', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Wavelia MWBI scan', 'description': 'Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion of detected lesions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '90.32', 'ciLowerLimit': '80.45', 'ciUpperLimit': '95.49', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "The sample size is calculated solely for the first primary endpoint, no minimal number of benign nor malignant lesions was set.\n\nThe sample size is calculated for this trial design, assuming a p1 = 75% and p0 = 60% for power (1-beta) of 80%, and an alpha level of 5%.\n\nWe will conclude that the Wavelia # 2 Microwave Breast Imaging system is effective in detecting breast lesions if more than 43 of the 62 subjects' lesions are detected."}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '21 days', 'description': 'Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI', 'unitOfMeasure': 'Dominant Lesions - Malignant & Benign', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Dominant Lesions - Malignant & Benign', 'denomUnitsSelected': 'Dominant Lesions - Malignant & Benign', 'populationDescription': 'Female patients who had a dominant discrete lesion in one breast who had a technically validated MWBI scan'}, {'type': 'SECONDARY', 'title': 'Correct Sizing of Breast Lesions With Wavelia MWBI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}, {'units': 'All Lesions - Malignant & Benign', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Wavelia MWBI scan', 'description': 'Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-67.7', 'upperLimit': '21.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '21 days', 'description': 'Endpoint: Maximal linear size difference (in mm) between the MWBI lesion detection and the maximal size reported in the ultrasound lesion size estimates. This is measured as a continuous variable of difference in mm', 'unitOfMeasure': 'mm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'All Lesions - Malignant & Benign', 'denomUnitsSelected': 'All Lesions - Malignant & Benign', 'populationDescription': 'Female patients for whom MWBI lesion size and Ultrasound lesion size data were obtained'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evaluate the Wavelia MWBI Breast Lesion Detectability Rate on Patients With no Biopsy Clip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Wavelia MWBI scan', 'description': 'Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion of detected lesions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '88.24', 'ciLowerLimit': '65.66', 'ciUpperLimit': '96.71', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The percentage of malignant and benign breast lesions correctly detected by Wavelia MWBI on patients that did not have a biopsy clip marking the lesion position in the breast, will be presented with 95% confidence interval.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '21 days', 'description': 'Endpoint: Percentage of breast lesions correctly detected with Wavelia MWBI on patients with no biopsy clip marking in their breast', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Female patients who did not have a biopsy clip in situ at time of MWBI scan'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Objective: Provide Further Data to Support the Establishment of the Safety Profile of MWBI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Wavelia MWBI scan', 'description': 'Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Proportion of patients with AEs', 'ciNumSides': 'TWO_SIDED', 'paramValue': '5.48', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '21 days', 'description': 'Endpoint: Incidence of Serious Adverse Events and Serious Adverse Device Effects during the total duration of the trial as well as other adverse events reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Female patients who consented to participate and had a complete or partial MWBI scan of at least one breast'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Wavelia MWBI scan', 'description': 'Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Device deficiency', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'All cysts aspirated before Wavelia scan', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'MWBI scan of only 1 breast', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Invalid MWBI scan - various reasons - positioning, breast too large, patient movement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'All female patients with an investigator assessed discrete breast abnormality of size \\>1cm and who were called to attend the symptomatic breast unit for assessment as per standard of care protocol were considered for participation in this clinical investigation. If eligibility was confirmed patients were enrolled into the study and were scheduled for an MWBI either before or after standard of care assessments'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Wavelia MWBI Scan', 'description': 'Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Overall Demographics', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '95'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'White Irish', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': 'Brazilian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Mauritian - South Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Romanian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Ireland', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-04', 'size': 382524, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-17T06:32', 'hasProtocol': True}, {'date': '2025-06-12', 'size': 377680, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-09-17T06:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients will have an MBI scan with Wavelia in addition to standard of care procedures'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2023-02-23', 'resultsFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-13', 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluate the Wavelia MWBI Breast Lesion Detectability Rate on Patients With no Biopsy Clip', 'timeFrame': '21 days', 'description': 'Endpoint: Percentage of breast lesions correctly detected with Wavelia MWBI on patients with no biopsy clip marking in their breast'}, {'measure': 'Safety Objective: Provide Further Data to Support the Establishment of the Safety Profile of MWBI Scan', 'timeFrame': '21 days', 'description': 'Endpoint: Incidence of Serious Adverse Events and Serious Adverse Device Effects during the total duration of the trial as well as other adverse events reported.'}], 'primaryOutcomes': [{'measure': 'Assess the Detectability Rate of Malignant and Benign Breast Lesions.', 'timeFrame': '21 days', 'description': 'Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI'}], 'secondaryOutcomes': [{'measure': 'Correct Sizing of Breast Lesions With Wavelia MWBI', 'timeFrame': '21 days', 'description': 'Endpoint: Maximal linear size difference (in mm) between the MWBI lesion detection and the maximal size reported in the ultrasound lesion size estimates. This is measured as a continuous variable of difference in mm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.\n\nMicrowave imaging is an emerging imaging modality for the early detection of breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at the microwave frequency spectrum.\n\nThis study is a pilot Clinical Evaluation of a microwave imaging system (Wavelia #2) for Breast Cancer Detection. The clinical data that will be collected in the context of this study is intended for the assessment of the imaging diagnostic capability and the safety of the investigational device.', 'detailedDescription': 'This study aims to enrol approximately 103 subjects presenting to the symptomatic breast unit with a breast abnormality who consent to undergo an Microwave Breast Imaging (MWBI) scan using the Wavelia #2 imaging system. The study uses an adaptive design to verify and validate the technical evolutions that have been integrated in the Wavelia# 2 prototype on a small patient dataset (30 patients). Once the technical performance has been established recruitment will continue to assess the clinical performance of the MBI system compared to standard of care reference imaging. The primary objectives of the study are to assess the performance of Wavelia # 2 in the detection of malignant and benign breast lesions, the sizing of malignant lesions for which post-surgery histology data will be available and the differentiation between benign and malignant breast abnormalities by means of features extracted from the MBI images.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent\n* Female subjects with an investigator assessed discrete breast abnormality of size \\> 1cm\n* Able and willing to comply with the requirements of this study protocol\n* Negative urine pregnancy test on the day of microwave imaging procedure (if of childbearing potential)\n* intact breast skin (i.e., without bleeding lesion, no evidence of inflammation and/or erythema of the breast)\n* Able to comfortably lie reasonably still in a prone position for approximately 15 minutes\n* Have had biopsy more than 2 weeks prior to the microwave breast investigation (if applicable)\n\nExclusion Criteria:\n\n* Have a cup size of A or whose breast is deemed too small to allow MBI assessment in the opinion of the investigator\n* Are pregnant or breast-feeding\n* Have had surgery on either breast within the past 12 months\n* Have any active or metallic implant other than a biopsy clip\n* Would be unsuitable for an MBI scan or unlikely to follow the protocol in the opinion of the Investigator'}, 'identificationModule': {'nctId': 'NCT05757427', 'briefTitle': 'Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection', 'organization': {'class': 'INDUSTRY', 'fullName': 'MVG Industries SAS'}, 'officialTitle': 'Open-label,Single Site,Pilot Clinical Investigation to Assess Detectability and Sizing of Invasive Breast Cancers,Detectability of Benign Breast Lesions,Differentiation Between Malignant and Benign Breast Lesions Using Wavelia # 2', 'orgStudyIdInfo': {'id': 'TP.102.17.22.PAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging.', 'description': 'Patients with an investigator assessed discrete breast abnormality of size \\>1cm and who attend the symptomatic breast unit for assessment as per standard of care protocol will be considered for participation in this clinical investigation.', 'interventionNames': ['Device: Wavelia #2']}], 'interventions': [{'name': 'Wavelia #2', 'type': 'DEVICE', 'description': 'Patients who are eligible and consent to have an MBI breast scan procedure will be asked to confirm their willingness to participate on the day of the breast scan. The patient will first have an Optical Breast Contour Detection (OBCD) scan, to reconstruct the external surface of the breast with high-precision, measure the total volume and the vertical extent of the breast before the MBI scan. The MBI scan will be performed on both breasts. The process will include optimization of breast positioning and breast cleaning to remove any transition liquid remaining on the skin.', 'armGroupLabels': ['All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Galway', 'country': 'Ireland', 'facility': 'Galway University Hospital/Symptomatic Breast Unit', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}], 'overallOfficials': [{'name': 'Michael Kerin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Galway University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MVG Industries SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}