Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-02-20 @ 6:14 PM
Study NCT ID:
NCT05458427
Status:
TERMINATED
Last Update Posted:
2024-02-26
First Post:
2022-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dedicated Breast CT for Diagnosis of Breast Cancer
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Unethical to include many more patients when currently obtained results are sufficient.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2022-07-06', 'studyFirstSubmitQcDate': '2022-07-11', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participant characteristics', 'timeFrame': 'Day of participation', 'description': 'Participant characteristics such as age, gender, ethnicity, race, cup size, reason of referral, family history for breast cancer, level of comfort during BCT examination and level of comfort of BCT compared to other image modality.'}], 'primaryOutcomes': [{'measure': 'Probability of malignancy (POM)', 'timeFrame': 'One year after the end of participation in this study', 'description': 'The primary objective of this study is to perform a prospective clinical trial to compare the performance of BCT and US (for soft tissue lesions) to that of the standard diagnostic work-up (several mammographic views and US for soft tissue lesions) for the diagnosis of breast cancer. The endpoint is the area under the receiver operating characteristic (ROC) curve (AUC) computed from probability of malignancy (POM) resulting from independent interpretation of the clinical diagnostic work-up images and the BCT images as produced by the BCT system + US (when acquired during standard clinical diagnostic workup).'}], 'secondaryOutcomes': [{'measure': 'Probability of malignancy (POM)', 'timeFrame': 'One year after the end of participation in this study', 'description': 'The secondary objective, a comparison is made among the clinical diagnostic work-up, the BCT images as produced by the system alone, and the BCT images enhanced using our novel algorithms alone. The endpoint is the area under the receiver operating characteristic (ROC) curve (AUC) computed from probability of malignancy (POM) resulting from independent interpretation images.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Computed Tomography'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Dedicated breast computed tomography (BCT) is being developed as a new x-ray based tomographic breast imaging method for early breast cancer detection and/or diagnosis. BCT results in isotropic high spatial resolution three-dimensional (3D) images coupled with high contrast resolution. It is hypothesized that BCT imaging used as a replacement of the additional mammographic views during diagnostic work-up will improve the accuracy of clinical standard diagnostic work-up.', 'detailedDescription': 'Rationale:\n\nDedicated breast computed tomography (BCT) is being developed as a new x-ray based tomographic breast imaging method for early breast cancer detection and/or diagnosis. BCT results in isotropic high spatial resolution three-dimensional (3D) images coupled with high contrast resolution. It is hypothesized that BCT imaging used as a replacement of the additional mammographic views during diagnostic work-up will improve the accuracy of clinical standard diagnostic work-up.\n\nObjective:\n\nThe primary objective of this research project is to determine the improvement in the area under the receiver operating characteristics (ROC) curve of BCT for diagnosis of breast cancer compared to that of the standard diagnostic work-up. As secondary objectives, this analysis will be performed by lesion type (microcalcifications vs. soft tissue lesions).\n\nStudy design:\n\nSingle arm study with each subject being its own control'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population base consists of women recalled to undergo diagnostic work-up due to a suspicious finding at mammographic screening for breast cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age 50 or older\n\nInitial schema:\n\n\\- Women who are scheduled to undergo a diagnostic work-up following an abnormal screening mammogram with the suspicious finding NOT located in the axillary tail of the breast This initial inclusion criterion will be used until 85 subjects that result in a Breast Imaging Reporting and Data System (BI-RADS) 1 or 2 after clinical diagnostic work-up are recruited and imaged.\n\nSubsequent schema:\n\n\\- Women who underwent diagnostic work-up following an abnormal screening mammogram and were assigned a BI-RADS 4 or 5 due to soft tissue lesions (total 120 patients when combined with those from the initial schema), or due to microcalcifications (total 120 patients when combined with those from the initial schema) with the suspicious finding NOT located in the axillary tail of the breast\n\nEach patient can only enroll once in the study.\n\nExclusion Criteria:\n\n* Women who do not meet the inclusion criteria as described above\n* Women with suspected or confirmed pregnancy\n* Women who have had bilateral mastectomy\n* Women whose suspicious lesion is located in the axillary tail\n* Women with prior breast cancer or breast biopsy in the recalled breast in the last 12 months\n* Women who are breastfeeding\n* Women who are very frail and unable to cooperate\n* Women who cannot give informed consent\n* Male subjects'}, 'identificationModule': {'nctId': 'NCT05458427', 'briefTitle': 'Dedicated Breast CT for Diagnosis of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Dedicated Breast CT for Diagnosis of Breast Cancer', 'orgStudyIdInfo': {'id': 'NL55378.091.15'}}, 'contactsLocationsModule': {'locations': [{'zip': '6500HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Netherlands Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}