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Clinical Trials/NCT03870659
NCT03870659
Completed
Not Applicable

Value of Abbreviated Breast MRI in Cancer Detection

Assiut University1 site in 1 country302 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
Assiut University
Enrollment
302
Locations
1
Primary Endpoint
To evaluate accuracy of abbreviated breast MRI in cancer detection
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
March 15, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

AShassan

Principle investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • All women referred to our radiology department at assiut university hospital for performing breast MRI
  • Exclusion Crieria:
  • no exclusion criteria

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To evaluate accuracy of abbreviated breast MRI in cancer detection

Time Frame: 2 years

Sensitivity and specificity of abbreviated breast MRI in detection of cancer will be calculated and compared to those of the full protocol

Study Sites (1)

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