Abbreviated Breast MRI in Cancer Detection

Breast Cancer Female Clinical Trial

Official title:

Value of Abbreviated Breast MRI in Cancer Detection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870659
• Other study ID #: Abbreviated Breast MRI
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: March 15, 2022

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: March 15, 2022
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Crieria:

• no exclusion criteria

Related Conditions & MeSH terms

• Breast Cancer Female

Intervention

Radiation:
• Breast MRI
Magnetic resonance imaging to the breast

Locations

Country	Name	City	State
Egypt	Zahraa	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate accuracy of abbreviated breast MRI in cancer detection	Sensitivity and specificity of abbreviated breast MRI in detection of cancer will be calculated and compared to those of the full protocol	2 years