The Diagnostic Efficacy of Computer-Aided Detection (CAD) in Full-Field Digital Mammography (FFDM)- A Prospective Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173303
First received: September 12, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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.


Condition
Breast Cancer
Breast Neoplasms

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 3000
Study Start Date: January 2006
Estimated Study Completion Date: January 2008
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 1.3 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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women for mammographic screening
  • women with breast disease

Exclusion Criteria:

  • pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00173303

Contacts
Contact: Jane Wang, MD 886-2-23123456 ext 5565 hstjen@yahoo.com.tw

Locations
Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan
Contact: Jane Wang, MD    886-2-23123456 ext 5565    hstjen@yahoo.com.tw   
Principal Investigator: Jane Wang, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Tiffany TF Shih, MD National Taiwan University Hospital
Principal Investigator: Jane Wang, MD National Taiwan University Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00173303     History of Changes
Other Study ID Numbers: 9461700528
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Breast neoplasms
Breast radiography
Cancer screening

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2014