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Dedicated Breast CT for Diagnosis of Breast Cancer.

We propose to perform a prospective trial to compare the accuracy of breast CT to the current standard imaging technologies for diagnosis of breast cancer in patients with a suspicious lesion identified during breast cancer screening.

Clinical evaluation of Contrast Enhanced Breast CT in women recalled from screening due to calcifications

Sensitivity of CEBCT for DCIS when focal enhancement around calcifications is deemed positive, and no enhancement is regarded as a negative test outcome.

Clinical evaluation of Contrast Enhanced Breast CT to improve Staging and treatment follow up in women with breast cancer

a. Staging of women with breast cancer, particularly those with extensive carcinoma in situ (DCIS):1) The concordance of tumor extent between CEBCT and large section histopathology2) The non-inferiority of CEBCT to contrast enhanced breast MRI for…

Clinical evaluation of 4D Breast Imaging for Personalized Breast Cancer Treatment

Part A: Determine the performance of using 4D DCE-BCT for tumour staging. Part B: Determine the performance of 4D DCE-BCT in monitoring of treatment response and prediction of final treatment outcome based on early response in patients that undergo…

Post-Market Clinical Investigation of the Clareon® IOL

Primary Objective:The primary objective of this study is to demonstrate the long-term (3 years) favorable visual acuity and adverse event outcomes for the Clareon IOL compared to historical SPE rates as reported in EN ISO 11979-7:2014.Secondary…