Breast Cancer
Conditions
Keywords
screening, MRI
Brief summary
Mammography remains an imperfect screening test especially in women with extremely dense breast tissue, missing biologically aggressive cancers especially in younger population and picking up indolent cancers that do not need treatment. The most sensitive test for breast cancer detection at our disposal is magnetic resonance imaging (MRI). The preliminary study of Dr Kuhl provide strong arguments that Ultra FAST Breast Magnetic Resonance is suitable for breast cancer screening with high sensitivity and specificity values. Data clearly demonstrates that FAST breast MRI could be the standard for breast cancer screening: it is safe, does not induce cancers, and can find more cancers than mammography. However this study was performed in women with low to moderately increased risk.The value of FAST Breast Magnetic Resonance in normal screening population has to be assessed before a modification of current strategy of breast cancer screening with mammography.
Interventions
PROCEDUREMRI screening
Diagnostic screening. The normal eligible screening population will first undergo a mammography, then an echography screening followed by a fast MRI screening.
Sponsors
Brugmann University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women referred for routine breast cancer screening
Exclusion criteria
* Disabled women (eg, unable to stand) * Pregnant women * Allergy to Gadolinium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR five point rating scale for mammography images | 24h | Two views (craniocaudal and mediolateral oblique) will be obtained of each breast with digital mammography by using a commercially available system. The reader will first interpret the digital mammography using a dedicated workstation.The radiologist will rate the images from each examination by using a standardized ACR five-point rating scale. Furthermore, if a reader records a positive score (\>2), mammographic features have to be specified (localization, number of ACR\>2 lesions,using predefined evaluation form). Scores are recorded directly into the PACS database and locked after each reading session. |
| ACR five point rating scale for echography images | 24h | After the digital mammography, the same reader will perform Ultrasound of both breasts using the transmitter of 10-13 MHertz (Acuson Antares (Siemens)). The reader will then interpret the ultrasound images using the same methodology as for digital mammography, described above (ACR five point rating scale). |
| ACR five point rating scale for MRI imaging | 24h | The same day, the Ultra FAST Breast Magnetic Resonance will be performed on 3T unit with 8 channel dedicated breast coil. Sequences: 3 Dimensional Gradient echo with Fat Saturation before and after Gadolinium injection (acquisition time 2 minutes). Initial post processing: MPR and automatic subtraction. The reader has to assess the MRI images using the same methodology as for digital mammography, according to the American College of Radiology Breast Imaging Reporting and Data System. |
Countries
Belgium
Outcome results
None listed