Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT03734432
Status:
UNKNOWN
Last Update Posted:
2018-11-08
First Post:
2018-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IGAR-Breast TeleOp Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-06', 'studyFirstSubmitDate': '2018-11-06', 'studyFirstSubmitQcDate': '2018-11-06', 'lastUpdatePostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ability for IGAR-Breast to perform breast biopsies teleoperatively', 'timeFrame': 'at time of sampling and pathological evaluation', 'description': 'analyzing the frequency of successful biopsy, in which the samples collected are of diagnostic quality as determined by radiologist'}], 'secondaryOutcomes': [{'measure': 'number and frequency of adverse events, device events and procedural deviations in addition to a comparison to results from previous trials for efficacy', 'timeFrame': 'During procedure', 'description': 'The number of times the local radiologist is required to participate will also be observed from a safety perspective'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diagnostic, Imaging, MRI'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to answer the question: can the IGAR-Breast safely and effectively perform teleoperative breast biopsies? This is a prospective, pilot trial. 5-10 participants will be selected by the radiologist and the success of biopsy analyzed. In addition the number of adverse events, device events and procedural deviations will be assessed to determine safety and efficacy.', 'detailedDescription': "In this prospective clinical trial, patients who present to the breast cancer clinic at one of the primary sites with suspected breast cancer requiring MRI-guided biopsy for diagnosis or staging will be screened consecutively. Patients who meet the inclusion criteria will be approached for consent to participate in the study. Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site. All consenting participants will be followed up for the assessment of the secondary outcome measure.\n\nA total of 5-10 participants will be consented for the pilot investigation.\n\nEach individual subject's participation is estimated to last approximately one week post procedure, with the trial itself expected to be completed within one year of its start date."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female subjects aged ≥ 18 years who require MRI-guided breast biopsy for diagnosis and/or staging Subjects are able to tolerate procedures for the MRI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects aged ≥ 18 years who require MRI-guided breast biopsy for diagnosis and/or staging Subjects are able to tolerate procedures for the MRI\n\nExclusion Criteria:\n\n* Subjects who refuse or are unable to give free and informed consent Subjects requiring more than one breast biopsy Subjects with breast implants or other foreign bodies Subjects for whom investigator determines IGAR-Breast enabled MRI-guided breast biopsy is not possible (size of subject, location of lesion, size of breast, etc.) Subjects who are pregnant or who plan to become pregnant during the course of the study'}, 'identificationModule': {'nctId': 'NCT03734432', 'acronym': 'IGAR-Breast-TO', 'briefTitle': 'IGAR-Breast TeleOp Trial', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'IGAR-Breast Teleoperative Clinical Investigation', 'orgStudyIdInfo': {'id': 'IGAR-TO-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'description': 'IGAR-Breast TeleOp', 'interventionNames': ['Device: IGAR-Breast TeleOp']}], 'interventions': [{'name': 'IGAR-Breast TeleOp', 'type': 'DEVICE', 'description': 'Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site.', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Mehran Anvari', 'role': 'CONTACT', 'email': 'anvari@mcmaster.ca', 'phone': '9055221155', 'phoneExt': '35058'}, {'name': 'Karen Barlow', 'role': 'CONTACT', 'email': 'kbarlow@stjoes.ca', 'phone': '905-522-1155', 'phoneExt': '33739'}, {'name': 'Mehran Anvari', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Colm Boylan', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'St. Josephs Healthcare Hamilton', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Belinda Curpen', 'role': 'CONTACT', 'email': 'Belinda.Curpen@sunnybrook.ca'}, {'name': 'Carrie Betel', 'role': 'CONTACT', 'email': 'carrie.betel@sunnybrook.ca'}, {'name': 'Belinda Curpen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Carrie Betel', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Calvin Law', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4R 0B7', 'city': 'Saint-Laurent', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Nathalie Duchesne', 'role': 'CONTACT', 'email': 'nathalie.duchesne@me.com'}, {'name': 'Nathalie Duchesne', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Imagix - Radiologie Saint-Laurent', 'geoPoint': {'lat': 45.50008, 'lon': -73.66585}}], 'centralContacts': [{'name': 'Karen Barlow', 'role': 'CONTACT', 'email': 'kbarlow@stjoes.ca', 'phone': '905-522-1155', 'phoneExt': '33739'}], 'overallOfficials': [{'name': 'Mehran Anvari', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Csii/St Joseph's Healthcare Hamilton"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': "St. Joseph's Healthcare Hamilton", 'class': 'OTHER'}, {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}