Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04764292
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2021-02-17
Brief Title:
Screening Contrast-Enhanced Mammography As an Alternative to MRI
Sponsor:
Wendie Berg
Organization:
University of Pittsburgh
Study Overview
Official Title:
Screening Contrast-Enhanced Mammography As an Alternative to MRI
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
SCEMAM
Brief Summary:
There are women for whom a screening breast MRI is clinically recommended but not feasible either due to patient factors body habitus pacemaker or other implant claustrophobia or access cost other constraints Contrast-enhanced mammography CEM is a potential alternative to MRI for screening that uses updated standard mammography equipment to obtain low- and high-energy images after intravenous injection of iodinated contrast as used in CT scanning The investigators seek to validate screening CEM as an alternative to screening MRI
Detailed Description:
This is a prospective study designed to evaluate the role of contrast enhanced mammography CEM in screening for breast cancer The overarching goal of the research program is to improve cancer detection on screening particularly in women with dense breasts MRI depicts more cancers than other screening methods including ultrasound MRI is proven to both improve cancer detection and reduce clinically detected cancers interval cancers after a negative screening mammogram in women with dense breasts PA Senate Bill 595 signed into law June 30 2020 requires insurance carriers to provide coverage for supplemental screening with MRI or ultrasound for a variety of indications Relative to the number of women who may benefit from screening MRI there is a shortage of equipmentcapacity Further nearly half of women cannot have an MRI for medical or other reasons such as claustrophobia implanted devices body habitus or cost deductible and copay apply even with the new legislation Contrast-enhanced mammography CEM appears to have similar performance to MRI but has not been widely validated particularly for screening In order to lay the foundation for improved screening of women with dense breasts the investigators seek to offer screening CEM as an alternative to MRI for women who meet guidelines for screening MRI but are unable to have MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None