Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03870659
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2019-03-08
Brief Title:
Abbreviated Breast MRI in Cancer Detection
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Value of Abbreviated Breast MRI in Cancer Detection
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 28 seconds when the MIP image alone was evaluated
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 28 seconds when the MIP image alone was evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None