Contrast-enhanced MR imaging of ductal carcinoma in-situ/invasive lobular carcinoma in supine position: a pilot study

Conditions: Borst diagnostisch verrichting
ductal carcinoma in-situ/invasive lobular carcinoma
10006291
Early stage breast cancer
10006232

Registration Number: NL-OMON41290

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

Histological proven invasive breast cancer with a DCIS (component) or pure ILC
Schedule for breast conserving therapy
A diagnositic contrast enhance MRI in prone position
Informed consent
><= 18 years old

Exclusion Criteria

Contra indication for MRI
Contra indication for gadolinium contrast administration

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary goal, diagnostic quality of supine CE-MRI, will be evaluated by 4<br /><br>radiologists. Each will compare the diagnostic quality with the prone CE-MRI in<br /><br>terms of supine is: better, equal or worse. The image quality of the supine<br /><br>scan will visually be judged on visibility of the lesion extent, in categories,<br /><br>excellent, reasonable, dubious, and impossible. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary parameter is the accuracy of deformable image registration<br /><br>between prone CE-MRI scans and supine non-CE-MRI scans. Registration accuracy<br /><br>will be assessed by defining a set of corresponding anatomical landmarks in<br /><br>both images before registration. After registration, the distance between<br /><br>corresponding anatomical landmarks defines the registration accuracy. The<br /><br>identification of landmarks will be performed by two radiologists. The first<br /><br>radiologist will define the landmarks on both the prone and the supine scan.<br /><br>The second radiologist will be provided with the landmarks of the other<br /><br>radiologist on the prone scan, and define the corresponding landmarks on the<br /><br>supine scan. An ANOVA method will be used to define registration accuracy,<br /><br>taking into account observer variation.</p><br>