Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00173303
Status:
UNKNOWN
Last Update Posted:
2005-09-15
First Post:
2005-09-12
Brief Title:
The Diagnostic Efficacy of Computer-Aided Detection CAD in Full-Field Digital Mammography FFDM- A Prospective Study
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
NOT_YET_RECRUITING
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:
The purpose of this study is to evalute whether CAD computer-aided detection in FFDM full-field digital mammography can facilitate the detection rate of breast cancer on mammography compared with FFDM without CAD
Detailed Description:
Mammography is currently the only documented effective imaging tool for breast cancer screening However the sensitivity of mammography may be reduced in dense breasts and sometimes it is difficult to even perceive a very subtle cancer which presents as a small stellate lesion or very faint microcalcifications missed diagnosed thus occurs Herein some researchers in Western countries developed computer-aided detection CAD system to help radiologists detect subtle easily overlooked findings to facilitate early breast cancer detection and most of the research regarding CAD was used in screen-film mammography SFM system Ikeda et al worked on the retrospective CAD usage of those negative mammograms which later developed breast cancers CAD could correctly mark 40 of the areas on these mammograms reported negative previously that later developed evident cancers However 80 of these are only nonspecific findings and do not warrant recall for additional workup even at retrospective unblinded review by well-trained mammographers The other research concluded that CAD could improve early cancer detection rate of mammography with the sensitivity of 92 in detection of breast cancer size smaller than 5mm 94 for cancer size 11-15mm CAD can detect more microcalcifications than masses sensitivity for microcalcifications 98 masses 84 mass with microcalcifications 92 CAD could mark an average of 13 false positive marks per mammographic exam
Full-field digital mammography FFDM is a new approved technology for breast cancer detection after SFM era since 2000 The diagnostic accuracy of FFDM versus SFM is still under clinical trials and it is believed the sensitivity and accuracy of FFDM for screening population is relatively equivalent to SFM However there are very few reports regarding the CAD application in FFDM since FFDM can offer the post-acquisition processing on high-resolution review workstation for interpretation Nevertheless the spatial resolution of soft-copy reading on monitors for FFDM is slightly inferior to but the contrast resolution is slightly superior to that of conventional SFM Herein the diagnostic efficacy and role of CAD in FFDM are still unclear Therefore the goal of our study is to explore the sensitivity false-negative FN and false-positive FP rates of combination usage of CAD in FFDM system in comparison with the sensitivity FN and FP rates of interpretation based on FFDM without CAD combination We are also about to evaluate the efficacy additional time spent in adjunct application CAD in FFDM interpretation in order to assess the feasibility of CAD in FFDM
Full-field digital mammography FFDM is a new approved technology for breast cancer detection after SFM era since 2000 The diagnostic accuracy of FFDM versus SFM is still under clinical trials and it is believed the sensitivity and accuracy of FFDM for screening population is relatively equivalent to SFM However there are very few reports regarding the CAD application in FFDM since FFDM can offer the post-acquisition processing on high-resolution review workstation for interpretation Nevertheless the spatial resolution of soft-copy reading on monitors for FFDM is slightly inferior to but the contrast resolution is slightly superior to that of conventional SFM Herein the diagnostic efficacy and role of CAD in FFDM are still unclear Therefore the goal of our study is to explore the sensitivity false-negative FN and false-positive FP rates of combination usage of CAD in FFDM system in comparison with the sensitivity FN and FP rates of interpretation based on FFDM without CAD combination We are also about to evaluate the efficacy additional time spent in adjunct application CAD in FFDM interpretation in order to assess the feasibility of CAD in FFDM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None