Ignite Creation Date:
2024-05-06 @ 1:11 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03954015
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2019-03-05
Brief Title:
Comparison of Three Methods for Early Detection of Breast Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Contrast Enhanced Ultrasound CEUS With US Microvessel Imaging Contrast Enhanced Dual Energy Mammography CEDM and Contrast Enhanced Breast MR CEMR Comparison of Three Methods for Early Detection of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-01
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:
Subjects with suspicious breast lesion BIRADS category 45 who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography CEDM Contrast Enhanced Breast MR CEMR and Contrast Enhanced Ultrasound CEUS
Detailed Description:
The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis
1 Positive predictive value of CEDM in detecting lesions seen on MR
2 Estimate the negative predictive value TNTNFN of CEUS as an adjunct
3 Compare the frequency of recommendation of biopsy of MGUS vs MGUS plus CEUS as an adjunct based on BIRADS scores
4 Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR
1 Positive predictive value of CEDM in detecting lesions seen on MR
2 Estimate the negative predictive value TNTNFN of CEUS as an adjunct
3 Compare the frequency of recommendation of biopsy of MGUS vs MGUS plus CEUS as an adjunct based on BIRADS scores
4 Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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