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Breast CancerNCT00173303

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

An observational study of Breast Cancer and Breast Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 90 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Breast Neoplasms
How many people
3,000 participants
Where
1 siteTaiwan
Study dates
Jan 2006to Jan 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • women for mammographic screening
  • women with breast disease

Who cannot join

  • pregnant women

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei

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

    Jane Wang, MD

Other trials in Taiwan

About this study

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.

Read the 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.

Keywords
Breast neoplasms, Breast radiography, Cancer screening
Medical subject headings
Breast Neoplasms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startJan 2006
  3. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Defined population
Time perspective
Other
Enrolment
3,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00173303
Sponsor's protocol ID
9461700528
Status last verified
Jun 2005
First submitted
12 Sep 2005
Last updated
15 Sep 2005
Results posted
No

Publications

  • Brem RF, Hoffmeister JW, Zisman G, DeSimio MP, Rogers SK. A computer-aided detection system for the evaluation of breast cancer by mammographic appearance and lesion size. AJR Am J Roentgenol. 2005 Mar;184(3):893-6. doi: 10.2214/ajr.184.3.01840893.

    PubMed 15728614

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Breast Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jane Wang, MD (886-2-23123456 ext. 5565, hstjen@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00173303, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2005.

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