Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
Study NCT ID:
NCT07145892
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2025-08-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Three-dimensional Digital Breast Tomosynthesis Versus Digital Mammography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2025-08-21', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between imaging findings and the final diagnosis', 'timeFrame': '6 months post-procedure', 'description': 'Correlation between imaging findings and the final diagnosis was calculated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Three Dimension', 'Digital Tomosynthesis', 'Digital Mammography', 'Diagnosis', 'Benign Breast Lesions', 'Asymptomatic Females']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare the supremacy of (3D) tomosynthesis versus (2D) digital mammography in the diagnosis of benign breast lesions in asymptomatic females.', 'detailedDescription': 'Most of the breast lesions are benign, but much concern is given to malignant lesions because breast cancer is the most common malignancy in women.\n\nMammography is the only study for screening in asymptomatic patients, and it is the initial imaging study in the diagnosis of symptomatic patients, with a sensitivity for suspicious lesions of 86% and a specificity of 57%.\n\nIn recent years, a significant effort has been expended to develop new approaches to breast imaging, one of which is the use of digital breast tomosynthesis (DBT), which is a pseudo three-dimensional digital mammography system that produces a series of thin-section reconstructed images from low-dose X-ray projections at multiple angles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective study was conducted on patients referred to the Diagnostic Radiology Department at Damanhur Educational Hospital and Tanta University.', 'genderDescription': 'Women with benign breast lesions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Women with benign breast lesions.\n\nExclusion Criteria:\n\n* Pregnant and lactating female.\n* Patients who refuse to fill the consent form.'}, 'identificationModule': {'nctId': 'NCT07145892', 'briefTitle': 'Three-dimensional Digital Breast Tomosynthesis Versus Digital Mammography', 'organization': {'class': 'NETWORK', 'fullName': 'The General Authority for Teaching Hospitals and Institutes'}, 'officialTitle': 'Three-dimensional Digital Breast Tomosynthesis Versus Digital Mammography: Which Get the Supremacy in Diagnosis of Benign Breast Lesions in Asymptomatic Females', 'orgStudyIdInfo': {'id': 'HD000217'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'Categorized 130 women aged from 30 to 40 years.', 'interventionNames': ['Device: Three-dimensional Digital Breast Tomosynthesis', 'Device: Two-dimensional Digital Mammography']}, {'label': 'Group II', 'description': 'Categorized 115 women aged from 40 to 50 years.', 'interventionNames': ['Device: Three-dimensional Digital Breast Tomosynthesis', 'Device: Two-dimensional Digital Mammography']}, {'label': 'Group III', 'description': 'Categorized 10 females aged above 50 years.', 'interventionNames': ['Device: Three-dimensional Digital Breast Tomosynthesis', 'Device: Two-dimensional Digital Mammography']}], 'interventions': [{'name': 'Three-dimensional Digital Breast Tomosynthesis', 'type': 'DEVICE', 'description': 'Patients underwent three-dimensional digital breast tomosynthesis.', 'armGroupLabels': ['Group I', 'Group II', 'Group III']}, {'name': 'Two-dimensional Digital Mammography', 'type': 'DEVICE', 'description': 'Patients underwent two-dimensional digital mammography', 'armGroupLabels': ['Group I', 'Group II', 'Group III']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'General Authority for Teaching Hospitals and Institutes', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The General Authority for Teaching Hospitals and Institutes', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Diagnostic Radiology, Damnhour National Medical Institute', 'investigatorFullName': 'Hekmat Samir Baumey', 'investigatorAffiliation': 'The General Authority for Teaching Hospitals and Institutes'}}}}