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

Conditions: breast cancer
Mamma calcifications
10006291

Registration Number: NL-OMON56633

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 539

Inclusion Criteria

- Women 50 to 75 years old
- Recalled from screening due to calcifications
- Planned to go for stereotactic biopsy

Exclusion Criteria

- Women with prior breast cancer
- Women who are very frail and unable to cooperate
- Women who cannot give informed consent
- Contraindication of iodine contrast (i.e., contrast allergy, renal function
impairment (GFR >=60 mL/min/1.73m2))
- Contraindication for irradiation (i.e., genetic mutation that predispose to
breast cancer)
- Male subjects

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the prevention of unnecessary biopsies<br /><br>and the non-invasive distinction between low grade (indolent) ductal carcinoma<br /><br>in situ (DCIS), and higher grade (potentially lethal) disease. In particular,<br /><br>prevention of the unnecessary biopsies will be a justified alternative<br /><br>solution, depending on the sensitivity of CEBCT for DCIS when focal enhancement<br /><br>around calcifications is deemed positive and no enhancement is regarded as a<br /><br>negative test outcome. In order to propose such a follow-up process instead of<br /><br>the stereotactic biopsy, reliable and high-performance metrics are needed. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. the frequency of enhancement on CEBCT near calcifications with a benign<br /><br>origin<br /><br>In order to calculate the frequency rate of enhanced areas on CEBCT near<br /><br>calcifications, the gold standard of histopathological verification is needed<br /><br>to identify their benign origin.<br /><br><br /><br>2. the association between enhancement patterns and histological grade of the<br /><br>disease<br /><br>Since the amount of enhancement is related to the aggressiveness of DCIS, we<br /><br>infer that signal intensities in CEBCT will also reflect biological<br /><br>aggressiveness. </p><br>