Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT03560102
Status:
TERMINATED
Last Update Posted:
2021-10-22
First Post:
2018-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018270', 'term': 'Carcinoma, Ductal, Breast'}], 'ancestors': [{'id': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christoph.binkert@ksw.ch', 'phone': '+41 52 266 2602', 'title': 'Christoph A Binkert (Sponsor-Investigator)', 'organization': 'Kantonsspital Winterthur'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Follow-up: Day 2, Day 8 (End of study)', 'eventGroups': [{'id': 'EG000', 'title': 'MR-HIFU Treatment', 'description': 'Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\\& resect model\n\nPhilips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR-HIFU Treatment', 'description': 'Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\\& resect model\n\nPhilips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.'}], 'classes': [{'categories': [{'measurements': [{'value': '168', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis)', 'unitOfMeasure': 'percentage of histopathological result', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Treatment Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR-HIFU Treatment', 'description': 'Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\\& resect model\n\nPhilips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'Effective treatment is defined as complete necrosis (100%) of targeted tumor including safety margin (\\>1mm) (histopathological analysis).\n\nSafety margin: measurement of smallest margin on histology and measurement of smallest margin on MRI. Parameter: Percentage of necrosis including safety margin', 'unitOfMeasure': 'percentage of necrosis of targeted tumor', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Adverse Events [Safety and Tolerability of the Treatment]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MR-HIFU Treatment', 'description': 'Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\\& resect model\n\nPhilips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0, 3, 8', 'description': 'Adverse events, general:\n\nPatients will be asked to report information about adverse events at each time point of the study. Information about time of onset, duration, resolution, action to be taken assessment of intensity, relationship with study treatment will be collected.\n\nAssessment of additional predefined safety parameters:\n\n\\- Skin changes, assessment in physical examination: presence/absence of redness, burn\n\n* Palpation breast: lump (mobility of lump related to skin: yes/no)\n* Pain, reported by patient', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MR-HIFU Treatment', 'description': 'Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\\& resect model\n\nPhilips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First patient enroled: 06JAN2020 Last patient completed: 05FEB2020', 'preAssignmentDetails': 'Due to difficulties in recruitment only 2 patients were screened for inclusion and only 1 patient met inclusion criteria and was enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MR-HIFU Treatment', 'description': 'Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\\& resect model\n\nPhilips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '163', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '65', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-31', 'size': 146370, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-23T08:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2018-05-14', 'resultsFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2018-06-15', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-23', 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Adverse Events [Safety and Tolerability of the Treatment]', 'timeFrame': 'Day 0, 3, 8', 'description': 'Adverse events, general:\n\nPatients will be asked to report information about adverse events at each time point of the study. Information about time of onset, duration, resolution, action to be taken assessment of intensity, relationship with study treatment will be collected.\n\nAssessment of additional predefined safety parameters:\n\n\\- Skin changes, assessment in physical examination: presence/absence of redness, burn\n\n* Palpation breast: lump (mobility of lump related to skin: yes/no)\n* Pain, reported by patient'}], 'primaryOutcomes': [{'measure': 'Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method)', 'timeFrame': 'Day 14', 'description': 'Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis)'}], 'secondaryOutcomes': [{'measure': 'Assessment of Treatment Efficacy', 'timeFrame': 'Day 14', 'description': 'Effective treatment is defined as complete necrosis (100%) of targeted tumor including safety margin (\\>1mm) (histopathological analysis).\n\nSafety margin: measurement of smallest margin on histology and measurement of smallest margin on MRI. Parameter: Percentage of necrosis including safety margin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer, Invasive Ductal']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy of a dedicated Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) unit in ablating breast cancer by comparing MR imaging and pathologic specimen after resection.\n\nSingle-center, single-arm, non-randomized trial', 'detailedDescription': 'The dedicated MR-HIFU unit has been shown to be safe and feasible to ablate breast tissue.\n\nThe planned study should address the possibility to completely ablate breast cancer with the dedicated breast MR-HIFU unit. The result of the MR-HIFU therapy should be monitored by imaging (contrast enhanced MRI) as well as with histopathological correlation after surgery.\n\nThe patient population would consist of female patients with proven breast cancer scheduled for surgical lumpectomy or mastectomy.\n\nThe idea is to evaluate a minimal invasive method to treat breast cancer as a potential alternative to surgical resection in the future'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* World Health Organization (WHO) performance status≤ 2\n* Body weight ≤ 80 kg\n* Biopsy proven invasive breast cancer with a size of ≤3.0cm (TNM classification: cT1-2 N0-2 MX ).\n* Histological type of tumor: invasive ductal carcinoma (IDC)\n* Patient is scheduled for surgical resection of tumor at study site\n* Tumor location within the reach of the HIFU transducers with the patient in prone position; distance from skin and pectoral muscle to the tumor ≥ 1.0 cm.\n* Target breast fits in the cup of the dedicated MR-HIFU breast system\n\nExclusion Criteria:\n\n* neoadjuvant systemic therapy\n* prior radiotherapy in target breast\n* contraindications for MRI\n* contraindication for application of gadolinium-based contrast agent\n* contraindication for procedural sedation analgesia\n* macro-calcifications in or around the targeted tumor\n* scar tissue or surgical clips in the direct path of the ultrasound beams\n* Women who are pregnant or breast feeding,\n* Intention to become pregnant during the course of the study,\n* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.\n* Known or suspected non-compliance, drug or alcohol abuse,\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,\n* Participation in another study with investigational drug/device within the 30 days preceding and during the present study,\n* Previous enrolment into the current study'}, 'identificationModule': {'nctId': 'NCT03560102', 'briefTitle': 'Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Winterthur KSW'}, 'officialTitle': 'Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer: Correlation Between MRI and Histology. Single-Center, Single-Arm, Non-Randomized Trial', 'orgStudyIdInfo': {'id': '2017-01282 (BASEC)'}, 'secondaryIdInfos': [{'id': '2017-MD-0021', 'type': 'OTHER', 'domain': 'Swissmedic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MR-HIFU treatment', 'description': 'Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\\& resect model', 'interventionNames': ['Device: Philips Sonalleve® MR-HIFU Breast Therapy System']}], 'interventions': [{'name': 'Philips Sonalleve® MR-HIFU Breast Therapy System', 'type': 'DEVICE', 'description': 'The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.', 'armGroupLabels': ['MR-HIFU treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-8401', 'city': 'Winterthur', 'country': 'Switzerland', 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}], 'overallOfficials': [{'name': 'Christoph A Binkert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kantonsspital Winterthur KSW'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Winterthur KSW', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}