Abbreviated Breast MRI in Cancer Detection

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Breast Cancer Female

Clinical Trial Details

NCT number	NCT03870659
Study type	Observational
Source	Assiut University
Contact
Status	Completed
Phase
Start date	April 1, 2019
Completion date	March 15, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.