Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 4:39 PM
Study NCT ID:
NCT01107860
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2010-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cone Beam Computed Tomography for Breast Imaging
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': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-14', 'studyFirstSubmitDate': '2010-01-05', 'studyFirstSubmitQcDate': '2010-04-20', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology', 'timeFrame': 'about 3 years', 'description': "The primary measure of this study will include the following aspects.\n\n* the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam\n* patient's comfort during the CBCT exam vs the mammographic exam\n* the concordance and discordance of CBCT breast imaging with standard mammography and other breast-imaging studies\n* the concordance and discordance of CBCT breast imaging with histopathology\n* number of participants with adverse events as a measure of safety"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to continue the investigation of cone beam computed tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing a compelling body of evidence incorporating non-contrast CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be selected from the patient population at a community based clinic, Elizabeth Wende Breast Care, LLC, which is located in Rochester, NY. Group I will consist of subjects who have had mammograms read as BIRADS® 1 or 2. Group II will be subjects who have had a diagnostic mammogram read as BIRADS® 4 or 5 prior to breast biopsy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup I:\n\n* Females at least 35 years of age of any ethnicity\n* Had a mammogram, read as BI-RADS® 1 or 2\n* Will undergo study imaging no later than four weeks from date of mammogram.\n* Is able to undergo informed consent.\n\nGroup II:\n\n* Females at least 35 years of age of any ethnicity\n* Require diagnostic imaging\n* Will undergo study imaging no later than four weeks from date of diagnostic mammogram\n* Is able to undergo informed consent\n\nExclusion Criteria:\n\nGroup I and Group II:\n\n* Pregnancy\n* Lactation\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, pace maker.\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': 'NCT01107860', 'briefTitle': 'Cone Beam Computed Tomography for Breast Imaging', 'organization': {'class': 'INDUSTRY', 'fullName': 'Koning Corporation'}, 'officialTitle': 'Cone Beam Computed Tomography for Breast Imaging', 'orgStudyIdInfo': {'id': 'KBCT-003'}, 'secondaryIdInfos': [{'id': '2R44CA103236-05A1', 'link': 'https://reporter.nih.gov/quickSearch/2R44CA103236-05A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'interventionNames': ['Device: Computed Tomography']}, {'label': 'Group II', 'interventionNames': ['Device: Computed Tomography']}], 'interventions': [{'name': 'Computed Tomography', 'type': 'DEVICE', 'description': 'In Group I, fifty CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.', 'armGroupLabels': ['Group I']}, {'name': 'Computed Tomography', 'type': 'DEVICE', 'description': 'In Group II , at least three hundred and fifty (350) study participants, who require diagnostic evaluation of the breast will undergo a breast CBCT . These subjects may be referred for biopsy as a result of a finding from a mammogram, ultrasound, MRI, or clinical exam.', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Elizabeth Wende Breast Care', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Posy Seifert, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elizabeth Wende Breast Care, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Koning Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Elizabeth Wende Breast Care, LLC', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}