Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT05486520
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2022-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-field MRI for Breast Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2022-08-01', 'studyFirstSubmitQcDate': '2022-08-01', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T1rho dispersion signal', 'timeFrame': '1 year', 'description': "Student's t-test to compare T1rho dispersion: a) in all participants between fat and fibroglandular tissues (expected difference); b) in patients between fat and cancer tissues (expected difference); and c) in patients between fibroglandular and cancer tissues (expected difference in dispersion curve)."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Breast pathologies benign', 'Breast pathologies malignant'], 'conditions': ['Breast Benign', 'Malignant Neoplasm of Breast', 'Breast Malignant Tumor']}, 'descriptionModule': {'briefSummary': 'This research study wants to learn more about improving the attainable image quality for ultra-low field MRI of the breast using new data acquisition methods(also called MRI pulse sequences) and image reconstruction algorithms.\n\nFor this pilot study, are testing a new method to image breast cancers at ultra-low magnetic field. The findings from this breast imaging technique will be compared with results obtained from standard mammograms, ultrasounds, MRIs, clinical examinations, and pathology evaluations, when available. The ultra-low field breast MRI performed for this study will be for research purposes and will not be used to guide clinical care.', 'detailedDescription': 'This research study is a Feasibility Study, which is the first-time investigators are examining the use of ultra-low field MRI to image breast cancer.\n\nThe purpose of the study is to develop, test and improve new software techniques for our magnetic resonance imaging (MRI) systems. In developing new, ultra-low field MRI scanners develop sequences and other software algorithms from time to time.\n\nThis study will enroll both healthy participants and persons with breast cancer. This investigation will also compare these images to standard mammograms, ultrasounds, MRIs, clinical examinations, and pathology evaluations when available.\n\nIt is expected that about 40 people will take part in this research study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent will be obtained from the adult volunteer subjects by the principal investigator, the coinvestigators, or the study staff prior to the imaging session. The investigator obtaining consent will explain in detail the protocol of the study, its purpose, and potential benefits to the society.\n* Subjects will be informed about the minimal risks of ultra-low magnetic fields) and of low-frequency nonionizing RF radiation involved in ultra-low field MR imaging. Subjects will also be informed about small space within the magnet. Unlike high-field scanners, there is essentially no sound produced by the imaging gradients, so hearing protection is not required.\n* Subjects will be informed that if they feel uncomfortable with the study, they can choose to terminate the study at any time. They will be informed that their refusal to participate in the study or choosing to terminate it at some point will have no effect on care and treatment received by them at MGH now or in future.\n* The subjects will be informed that their personal information will be protected as per the HIPAA guidelines.\n* The subjects will have at least 15 minutes to consider participation.\n* Subjects will undergo MR contraindication screening to ensure that they meet the basic inclusion/exclusion criteria for the study and give written informed consent immediately prior to the MR imaging study.\n* Recruit adult female volunteers of any race or ethnic background, between the ages of 20 to 80, who are either scheduled for breast imaging and/or a percutaneous biopsy.\n* All efforts will be taken to find interpreters for volunteers who do not understand English, enabling them to be screened and consented with the short-form consent form so that they may participate in this study.\n\nExclusion Criteria:\n\n* Exclusion criteria include MR contraindications\n* Electronic implants such as cardiac pacemakers or perfusion pumps\n* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants\n* Ferromagnetic objects such as jewelry or metal clips in clothing\n* Pregnant or breast feeding women\n* A history of uncontrolled seizures\n* Claustrophobia\n* Any greater than normal potential for cardiac arrest\n* Subjects less than 18 years of age or over 80 years of age.'}, 'identificationModule': {'nctId': 'NCT05486520', 'briefTitle': 'Low-field MRI for Breast Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A New Breast Cancer MRI Biomarker Using the Intrinsic T1rho Signal', 'orgStudyIdInfo': {'id': '21-579'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BREAST MRI IMAGES FROM HEALTHY VOLUNTEERS', 'description': 'All participants will be recruited prior to their scheduled diagnostic imaging or diagnostic procedures.\n\nThe expected time to complete the study is a maximum of 1.5 hours with approximately 30-60 minutes of scan time, depending on the specific MRI software being tested.', 'interventionNames': ['Device: Magnetic Resonance Imaging (MRI)']}, {'type': 'EXPERIMENTAL', 'label': 'BREAST MRI IMAGES FROM PERSONS WITH KNOWN BREAST PATHOLOGIES BENIGN AND MALIGNANT', 'description': 'All participants will be recruited prior to their scheduled diagnostic imaging or diagnostic procedures.\n\nThe expected time to complete the study is a maximum of 1.5 hours with approximately 30-60 minutes of scan time, depending on the specific MRI software being tested.', 'interventionNames': ['Device: Magnetic Resonance Imaging (MRI)']}], 'interventions': [{'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'DEVICE', 'description': 'MR images will be acquired using an ultra-low magnetic field 6.5 mT scanner located at the Martinos Center. The study time is estimated to be a maximum of 90 minutes with a maximum of 60 minutes of imaging time', 'armGroupLabels': ['BREAST MRI IMAGES FROM HEALTHY VOLUNTEERS', 'BREAST MRI IMAGES FROM PERSONS WITH KNOWN BREAST PATHOLOGIES BENIGN AND MALIGNANT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Matthew S Rosen, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'MGH - Contact the Partners Innovations team at http://www.partners.org/innovation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Matthew S. Rosen, Ph.D.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}