Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT01588834
Status:
COMPLETED
Last Update Posted:
2016-05-20
First Post:
2012-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Histology of Functional Density in Premenopausal Breast
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'core biopsy samples from mammographically dense breast tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-19', 'studyFirstSubmitDate': '2012-04-26', 'studyFirstSubmitQcDate': '2012-04-27', 'lastUpdatePostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of epithelium vs stroma', 'timeFrame': 'within 3 days of functional density assessment on MBI'}], 'secondaryOutcomes': [{'measure': 'Degree of lobular involution', 'timeFrame': 'within 3 days of functional density assessment on MBI', 'description': 'Degree of lobular involution as assessed through qualitative and quantitative measurements will be compared between dense tissue which appears photopenic on MBI and dense tissue which appears functionally active on MBI.'}, {'measure': 'Ki-67 cellular proliferation index', 'timeFrame': 'within 3 days of functional density assessment on MBI', 'description': 'Degree of cellular proliferation as assessed through Ki-67 index will be compared between dense tissue which appears photopenic on MBI and dense tissue which appears functionally active on MBI.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dense Breasts', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '41402965', 'type': 'DERIVED', 'citation': 'Bardwell Speltz L, Ghosh K, Visscher DW, Scott CG, Cole KC, Kroneman TN, Maxwell RW, Conners AL, Hunt KN, Rhodes DJ, Vachon CM, Hruska CB. Histologic correlates of background parenchymal uptake on molecular breast imaging. Breast Cancer Res. 2025 Dec 16;27(1):216. doi: 10.1186/s13058-025-02171-x.'}], 'seeAlsoLinks': [{'url': 'http://newsblog.mayoclinic.org/2008/09/03/breast-cancer-molecular-breast-imaging-mammography/', 'label': 'Mayo Clinic News'}, {'url': 'http://www.youtube.com/watch?v=DOQBLe8MdH0', 'label': 'Mayo Clinic You Tube Channel'}]}, 'descriptionModule': {'briefSummary': "The investigators hypothesize that knowledge of the functional behavior of areas of mammographic density will enable more specific identification of dense tissue at-risk for breast cancer, ultimately providing predictive information on an individual's risk of developing breast cancer.", 'detailedDescription': 'The specific aims are:\n\n* In women with increased mammographic density (MD), determine the histological characteristics of functionally dense tissue compared to that of non-functionally dense tissue via core-needle biopsy of the breast.\n* In women with increased mammographic density (MD), determine the correlations between the total percent area of functional density (FD) on MBI, percent density of MD on mammogram, and histological characteristics of dense tissue'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with mammographically dense breasts who demonstrate either photopenic or marked background parenchymal uptake on MBI', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 40 - 55 years\n* Considered premenopausal or peri-menopausal\n* Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates\n* Negative/benign assessment (BIRADS category 1-2) or Additional imaging recommended (BIRADS category 0), where the subsequent diagnostic workup results in a final negative/benign assessment (BIRADS category 1-2).\n* No proliferative benign lesions (e.g. fibroadenomas) identified\n* Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3 or 4)\n* MBI performed less than 3 days prior to biopsy demonstrating either marked FD or photopenic FD in an area of mammographically dense tissue amenable to biopsy.\n* No use of exogenous hormonal drugs (e.g. hormonal contraceptives or sex steroid hormones) within six months prior to study biopsy\n* Negative pregnancy test or surgically sterilized (for patients in whom a study MBI will be performed)\n\nExclusion criteria:\n\n* Using any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase inhibitors within six months prior to study biopsy.\n* Prior diagnosis of bilateral breast cancer.\n* Diagnosis of breast cancer in either breast within 3 years prior to study MBI.\n* Diagnosis of any cancer, except breast cancer (see #3) or non-melanomatous skin cancer, for which patient has not been disease free for at least 5 years.\n* Current breast symptoms\n* Breast implants\n* Known allergy to local anesthetic.\n* History of bleeding complications from prior interventions\n* Current use of anticoagulants (e.g., Coumadin or other blood thinners)\n* Major medical condition'}, 'identificationModule': {'nctId': 'NCT01588834', 'briefTitle': 'Histology of Functional Density in Premenopausal Breast', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women', 'orgStudyIdInfo': {'id': '12-000458'}}, 'armsInterventionsModule': {'interventions': [{'name': 'breast biopsy', 'type': 'PROCEDURE', 'description': 'ultrasound-guided core needle biopsy of healthy, mammographically dense breast tissue'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Carrie B Hruska, PhD R-D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Carrie Hruska', 'investigatorAffiliation': 'Mayo Clinic'}}}}