Image quality of MR-Imaging on the MR-High Intensity Focused Ultrasound breast system

Completed

Conditions: benign tumor originating from glandular tissue
fibroadenoma
10006288

Registration Number: NL-OMON36389

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Inclusion criteria for volunteers:
Women
Age >= 18 years
Weight < 80 kg
Physical fitness to lie in the MRI scanner for a maximum duration of 1 hour;Inclusion criteria for patients with fibroadenomas:
Women
Age >= 18 years
Weight < 80 kg
Physical fitness to lie in the MRI scanner for a maximum duration of 1 hour
One or more histological proven fibroadenomas

Exclusion Criteria

Exclusion criteria for volunteers and patients with fibroadenomas:
Contra-indications to MRI scanning according to the guidelines of the hospital
Pregnant or lactating women
Volunteers and patients who don*t want to be informed about unexpected findings.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoints are:<br /><br>- image quality --> assessed by a score based on delineation of anatomical<br /><br>structures, contrasts, SNR and artefacts of both MRI scans.<br /><br>- lesion descriptors of the BI-RADS lexicon in patients with a fibroadenoma --><br /><br>described by shape and margin of the lesion and other findings on the MRI scans<br /><br>(e.g. edema, lymphadenopathy, skin thickening). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints<br /><br>- geometric deformation in breasts with different sizes --> assessed by<br /><br>overlaying the two MRI scans and assess whether there is deformation and assess<br /><br>the variety of deformation in breasts with different sizes.<br /><br>- size of fibroadenoma --> assessed by scoring the maximum diameter of the<br /><br>fibroadenoma in 3 orthogonal planes (MaxTrans, MaxSag, MaxCor) on both MRI<br /><br>scans.<br /><br>- relative position of the fibroadenoma --> assessed by measuring the shortest<br /><br>distance from the fibroadenoma to the musculus pectoralis, the chest wall and<br /><br>the skin in 3 orthogonal planes (MaxTrans, MaxSag, MaxCor) on both MRI scans. </p><br>