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Not Yet Recruiting NCT07865884

Tissue Validation of Mammographic Breast Arterial Calcification in Mastectomy Specimens

Conditions: Breast Cancer, Vascular Calcification, Coronary Artery Calcification, Atherosclerosis Cardiovascular Disease

Sex: Female
Ages: 40 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Summary

Breast arterial calcification (BAC) is a common incidental finding on screening mammograms and has been associated with cardiovascular disease in women. However, every study in this field has been imaging-based. The accuracy of mammography for detecting breast arterial calcification has only ever been measured against another radiologist reading the same mammogram, never against the tissue itself. As a result, it is not known how much calcification mammography misses, nor whether what it shows represents medial (Monckeberg-type) calcification or true atherosclerosis. This prospective observational study compares mammographic BAC with the histopathology of breast arteries obtained from mastectomy specimens. Women aged 40 years and older undergoing upfront mastectomy, without neoadjuvant therapy, for invasive breast cancer or ductal carcinoma in situ will be enrolled consecutively. Additional tissue blocks will be taken from tumour-free areas of the specimen and examined with von Kossa and elastic van Gieson stains to determine whether arterial calcification is present and whether it lies in the media or the intima. These findings will be compared with the preoperative mammogram, which is read independently and blind to the pathology result. As a secondary and exploratory objective, coronary artery calcification will be scored from staging computed tomography images already acquired for cancer staging. No additional tests, imaging, radiation exposure or blood sampling will be performed for the purposes of this study, and the surgical procedure will not be altered in any way.

Eligibility Criteria

Inclusion Criteria: * Female * Aged 40 years or older * Scheduled for mastectomy for invasive breast carcinoma or ductal carcinoma in situ. All mastectomy types are eligible: simple, modified radical, skin-sparing, nipple-sparing and subcutaneous * Full-field digital mammogram performed within 6 months before surgery and available for review * Written informed consent Exclusion Criteria: * Neoadjuvant chemotherapy or neoadjuvant endocrine therapy * Previous surgery or radiotherapy to the ipsilateral breast * Previous radiotherapy to the thoracic region * Breast implant * Inflammatory breast carcinoma * Male breast cancer * Chronic haemodialysis treatment * Known hereditary disorder of vascular calcification * Only analogue film mammography available * Mammographic images not assessable

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Source: ClinicalTrials.gov (NCT07865884). StuddyBuddy aggregates publicly available trial information.