Clinical trial NCT02324894: Initial Evaluation of Ultra FAST Breast Magnetic Resonance in Breast Cancer Screening: Comparative Study With Mammography and Ultrasound.
Official title: Initial Evaluation of Ultra FAST Breast Magnetic Resonance in Breast Cancer Screening: Comparative Study With Mammography and Ultrasound.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: screening
MRI
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* Women referred for routine breast cancer screening

Exclusion Criteria:

* Disabled women (eg, unable to stand)
* Pregnant women
* Allergy to Gadolinium

Primary outcomes:
measure: ACR five point rating scale for mammography images
timeFrame: 24h
measure: ACR five point rating scale for echography images
timeFrame: 24h
measure: ACR five point rating scale for MRI imaging
timeFrame: 24h
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Tadeusz Stadnik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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