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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00173303
Recruitment Status : Unknown
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
Information provided by:
National Taiwan University Hospital

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.

Condition or disease
Breast Cancer Breast Neoplasms

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.

Study Type : Observational
Enrollment : 3000 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Study Start Date : January 2006
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • women for mammographic screening
  • women with breast disease

Exclusion Criteria:

  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00173303

Contact: Jane Wang, MD 886-2-23123456 ext 5565

National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan
Contact: Jane Wang, MD    886-2-23123456 ext 5565   
Principal Investigator: Jane Wang, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Study Director: Tiffany TF Shih, MD National Taiwan University Hospital
Principal Investigator: Jane Wang, MD National Taiwan University Hospital

Publications of Results: Identifier: NCT00173303     History of Changes
Other Study ID Numbers: 9461700528
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 15, 2005
Last Verified: June 2005

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

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