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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36389

Enrollment

Registered

2011-08-19

Start date

2011-09-07

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benign tumor originating from glandular tissue fibroadenoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for volunteers: Women Age >= 18 years Weight = 18 years Weight

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results