Clinical trial NCT03870659: Abbreviated Breast MRI in Cancer Detection
Official title: Value of Abbreviated Breast MRI in Cancer Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 302
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women referred for performing breast MRI to exclude presence of breast cancer and their lesion characterization

Brief summary: Breast cancer is one of the leading causes of death among women, with early detection being the key to improve prognosis and survival.

Randomized controlled trials have found that screening mammography has decreased the mortality of breast cancer by 30%.

However, with a sensitivity of 70%, mammography has its limitations particularly in women with dense breasts.

The use of breast MRI for screening has increased over the past decade. Most experiences exist in women at elevated familial risk of breast cancer. In these women, MRI screening shifts the stage distribution of breast cancers toward lower stages and reduces the fraction of interval cancers.

Kuhl et al in 2014 were the first to report on the feasibility of an abbreviated breast MRI protocol for breast cancer screening. Their protocol consisting of an unenhanced T1-weighted and first contrast-enhanced T1-weighted sequence, subtraction imaging, and a single MIP image.

This groundbreaking study found that image acquisition and interpretation time could be reduced without having a negative impact on diagnostic accuracy.

Detailed description: Breast MRI screening is associated with high direct and indirect costs. These, together with the lack of sites that offer high-level breast MRI, limit clinical access to screening MRIs.

One reason for the high cost is that current breast MRI protocols are time consuming to acquire and read. A typical MRI study occupies the MRI system for up to 40 minutes and generates several hundred images.

DCE-MRI allows the assessment of high-resolution breast morphology and enhancement kinetics to depict angiogenesis as a tumor-specific feature. At any given field strength, DCE-MRI is the most sensitive modality for breast cancer detection, with a pooled sensitivity of 93%; DCE-MRI has good pooled specificity of 71%.

With the abbreviated MRI protocol, the acquisition time was substantially decreased to 3 minutes, compared with 17 minutes for the full diagnostic protocol. The interpretation time of the abbreviated protocol was 28 seconds on average and 2.8 seconds when the MIP image alone was evaluated.

Eligibility criteria: Inclusion Criteria:

- All women referred to our radiology department at assiut university hospital for performing breast MRI

Exclusion Crieria:

* no exclusion criteria

Primary outcomes:
measure: To evaluate accuracy of abbreviated breast MRI in cancer detection
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Zahraa
Study officials:
affiliation: Assiut University
name: Abeer, PhD
role: STUDY_DIRECTOR
References: