Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:18 PM
Study NCT ID:
NCT07487792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Imaging Breast Implants With a Transmission-based Microwave Scanner
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of regions of interest in microwave images', 'timeFrame': '12 months', 'description': 'Images of both breasts will be created. Regions of interest corresponding to the breast implants will be identified using the electrical properties. The size of these regions will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Comparison of total area in implant in microwave image with known physical size', 'timeFrame': '12 months', 'description': 'The total area corresponding to the breast implant in the microwave images will be calculated and compared with the known implant size.'}, {'measure': 'Compare microwave scans of the left and right breast', 'timeFrame': '12 months', 'description': 'The properties and size of the region corresponding to the implant will be compared between right and left breasts.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['women', 'breast implant'], 'conditions': ['Breast - Female']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Mojabi, Pedram, et al. "Feasibility of Tumor Detection with a Transmission-based Microwave Imaging System." Medical Physics (Lancaster), vol. 52, no. 9, 2025, pp. e18080-n/a, https://doi.org/10.1002/mp.18080.'}, {'type': 'BACKGROUND', 'citation': 'Mojabi, Pedram, et al. "Assessment of Breast Composition with A Transmission-Based Microwave Imaging System." IEEE Transactions on Biomedical Engineering, vol. 73, no. 1, 2025, pp. 1-11, https://doi.org/10.1109/TBME.2025.3584669.'}, {'type': 'BACKGROUND', 'citation': 'Mojabi, Pedram, et al. "Point-of-Care Breast Imaging for Monitoring Neoadjuvant Treatment: Case Studies with Transmission-Based Microwave Imaging." IEEE Transactions on Biomedical Engineering, vol. PP, 2025, pp. 1-10, https://doi.org/10.1109/TBME.2025.3599516.'}, {'type': 'BACKGROUND', 'citation': 'Smith, K., et al. "Microwave Imaging of the Breast: Consistency of Measurements Over Time." IEEE Journal of Electromagnetics, RF and Microwaves in Medicine and Biology, vol. 6, no. 1, 2022, pp. 61-67, https://doi.org/10.1109/JERM.2021.3099014.'}, {'type': 'BACKGROUND', 'citation': 'Butterworth, Carina M., et al. "Quantifying Consistency of Microwave Breast Imaging: Laser Scanning for Assessing Breast Volume and Shape." IEEE Journal of Electromagnetics, RF and Microwaves in Medicine and Biology, vol. 9, no. 3, 2025, pp. 335-43, https://doi.org/10.1109/JERM.2025.3531693.'}, {'type': 'BACKGROUND', 'citation': 'Mojabi, Pedram, et al. "Microwave Imaging for Breast Cancer Detection: Performance Assessment of a Next-Generation Transmission System." IEEE Transactions on Biomedical Engineering, vol. 72, no. 6, 2025, pp. 1787-99, https://doi.org/10.1109/TBME.2024.3521410.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess whether microwave scans can depict the presence of implants in the breast in women with existing breast implants that were surgically placed at least 6 months ago. The main questions it aims to answer are:\n\n1. Can a microwave imaging device effectively scan a breast containing implants?\n2. Can the presence of implants be identified in a microwave scan?\n3. Can the microwave scans of the left and right breasts be compared to assess whether similarity is observed?', 'detailedDescription': 'Breast implants are consistently one of the top 5 cosmetic procedures performed each year in North America. The Food and Drug Administration (FDA) cites a 10% risk of rupture over 10 years (1% cumulative per annum risk of device rupture).\n\nRupture refers to disruption in the integrity of the implant, and is typically age-related deterioration where age in this context refer to the implant. Rupture in saline implants is detected with rapid change in breast size. With silicone implants, rupture is much more challenging to detect as it is rare to have a completely collapsed implant shell.\n\nCurrent recommendations for surveillance of breast implants include Magnetic Resonance Imaging (MRI) or ultrasound within 5-6 years of surgery for the initial test, then every 2-3 years. The guideline initially included only MRI but was adjusted in 2022 to include ultrasound. Patient adherence to guidelines with only MRI was very low (less than 5%), which is postulated to relate to the expense, discomfort, and inaccessibility of MRI. Mammography is a frequently used breast imaging method. However, the majority of women with implants are too young for breast screening programs that involve regular mammograms. Also, the implant is displaced during mammography to focus on the breast tissues. Finally, mammography involves exposure to x-rays, limiting regular scans in women too young for screening.\n\nTherefore, there is a need to regularly inspect silicone implants for silent rupture. An imaging approach that is low-cost, available at point-of-care, easy to use, and reliable (i.e. sensitive to implant rupture) would be a valuable tool for plastic surgery clinics.\n\nMicrowave imaging has been proposed as a low-cost and comfortable approach to breast imaging that can be performed at point of care. This approach to imaging is low power, so no tissue heating occurs and there are no other side effects. Therefore, microwave imaging is suited to in-clinic, ongoing monitoring of the breast.\n\n10 women with breast implants will be recruited from plastic surgery clinics. This includes women with breast implants that were surgically placed at least 6 months prior and are asymptomatic for implant rupture, as well as women who have implants with a confirmed rupture. Study participants will be scanned with the microwave imaging system. Three scans of each breast will be collected in each of the Craniocaudal (CC) and Mediolateral Oblique (MLO) views.\n\nThe breast positioning will be adjusted between scans to maximize the presentation of the implant in the imaging volume. The images will be analyzed to identify the implants, as the implants have different properties when compared to healthy breast tissues.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with breast implants placed at least 6 months prior who are asymptomatic for implant rupture as well as those with known implant rupture\n* Female\n* Minimum of 18 years of age\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Women who are currently pregnant or breastfeeding\n* Women with active breast infections\n* Women with nipple piercings (unless removed prior to scanning)\n* Women with implanted electronic device\n* Women with physical limitations that prevent them from placing their breasts inside the scanner'}, 'identificationModule': {'nctId': 'NCT07487792', 'briefTitle': 'Feasibility of Imaging Breast Implants With a Transmission-based Microwave Scanner', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Feasibility of Imaging Breast Implants With a Transmission-based Transmission Scanner', 'orgStudyIdInfo': {'id': 'REB25-0914'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A single arm study to determine feasibility of imaging breast implants', 'description': 'WVI-MIS-03-2025', 'interventionNames': ['Device: WVI-MIS-03-2025']}], 'interventions': [{'name': 'WVI-MIS-03-2025', 'type': 'DEVICE', 'description': 'Microwave scans', 'armGroupLabels': ['A single arm study to determine feasibility of imaging breast implants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3H 3K8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'contacts': [{'name': 'Anita Garland', 'role': 'CONTACT', 'email': 'anita.garland@ucalgary.ca', 'phone': '403-703-1664'}], 'facility': 'Demsey Plastic Surgery Clinic', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Anita Garland', 'role': 'CONTACT', 'email': 'anita.garland@ucalgary.ca', 'phone': '403-703-1664'}, {'name': 'Elise Fear', 'role': 'CONTACT', 'email': 'fear@ucalgary.ca', 'phone': '403-210-5413'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wave View Imaging Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Elise Fear', 'investigatorAffiliation': 'University of Calgary'}}}}