Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-03 @ 2:34 AM
Study NCT ID:
NCT01750320
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2012-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Koning Breast Computed Tomography Guided Biopsy
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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2012-12-12', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of Koning breast CT-guided biopsy', 'timeFrame': 'about 1 year', 'description': 'The goal of this study is to evaluate the concordance of Koning Breast CT-guided Biopsy (KBCT-GBx) results to diagnostic work-up imaging (at least mammographic) and KBCT imaging and to verify that the localization and guidance accuracy of KBCT-GBx is at least equivalent to stereotactic-guided biopsy to validate the localization and guidance accuracy of KBCT-GBx.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast CT', 'Biopsy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to show that the accuracy of Koning Breast CT-guided biopsy is at least equivalent to that of stereotactic-guided biopsy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female at least 35 years of age of any ethnicity\n* Lesion seen on mammography\n* Diagnostic report read as BI-RADS 4 or 5\n* Will undergo biopsy no later than four weeks from date of mammogram\n* Is able to undergo informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactation\n* Subjects with breast implants\n* Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pacemaker.\n* Subjects who are unable to tolerate study constraints.\n* Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)\n\n * Treatment for enlarged thymus gland as an infant\n * Irradiation for benign breast conditions, including breast inflammation after giving birth\n * Treatment for Hodgkins disease\n* Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.\n* Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)\n\n * Tuberculosis\n * Severe scoliosis'}, 'identificationModule': {'nctId': 'NCT01750320', 'briefTitle': 'Koning Breast Computed Tomography Guided Biopsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Koning Corporation'}, 'officialTitle': 'Koning Breast CT-guided Biopsy Phase I Trial', 'orgStudyIdInfo': {'id': 'KBCT-004'}, 'secondaryIdInfos': [{'id': 'W81XWH-09-1-0441', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense (DOD) Telemedicine and Advanced Technology Research Center (TATRC)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Koning Breast CT - guided Biopsy', 'interventionNames': ['Device: Koning Breast CT-guided Biopsy']}], 'interventions': [{'name': 'Koning Breast CT-guided Biopsy', 'type': 'DEVICE', 'description': 'The breast will be positioned and stabilized in the grid/compression device. Four KBCT scans will be taken to guide the vacuum-assisted biopsy procedure.', 'armGroupLabels': ['Koning Breast CT - guided Biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Elizabeth Wende Breast Care', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Koning Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Elizabeth Wende Breast Care, LLC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}