Breast CancerNCT00450359
Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography
A study testing breast imaging study, comparison of screening methods and radiomammography in people with Breast Cancer, run by Aberdeen Royal Infirmary at 4 sites in United Kingdom.
Trial summary
RATIONALE: A computer-aided detection program may help doctors find breast cancer sooner, when it may be easier to treat, in women undergoing screening mammography. PURPOSE: This randomized clinical trial is studying how well computer-aided breast cancer detection works in women undergoing screening mammography. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- breast imaging study, comparison of screening methods and radiomammography
- Type of treatment
- Surgery or procedure
- How many people
- 30,000 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Sep 2006to Oct 2008
- Phase
- Interventional
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Currently undergoing 2-view mammography for routine breast cancer screening at any of the following participating National Health Services Breast Cancer Screening Program centers:
- Manchester
- Coventry
- Nottingham
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Walsgrave Hospital
Coventry, England, CV2 2DX
Withington Hospital
Manchester, England, M20 8LR
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
About this study
Official title: A Prospective Evaluation of Computer Aided Detection (CAD) in the NHS Breast Screening Programme [CADET II]
RATIONALE: A computer-aided detection program may help doctors find breast cancer sooner, when it may be easier to treat, in women undergoing screening mammography.
PURPOSE: This randomized clinical trial is studying how well computer-aided breast cancer detection works in women undergoing screening mammography.
Read the detailed description
OBJECTIVES:
- Compare, prospectively, the breast cancer detection rate and recall rate of single reading using computer-aided detection vs standard double reading in women undergoing screening mammography.
OUTLINE: This is a prospective, randomized, multicenter study. Participants are randomized to 1 of 3 screening arms.
- Arm I (double reading): Screening mammograms are independently reviewed by two readers (i.e., radiologist or radiographer), each of whom reports on any abnormalities and decides whether a participant is recalled for further assessment or returned home to routine screening. In the event there is disagreement between the readers' findings, a third reader acts as an arbitrator by rendering an interpretation of the mammogram and making the final decision to recall the participant or return to routine screening.
- Arm II (single reading with computer-aided detection [CAD]): Screening mammograms are reviewed initially by a single reader who reports on any abnormalities. The reader then re-examines the mammogram with the aid of CAD, a system that uses computer prompts to recall suspicious features or abnormalities that may have been overlooked or previously dismissed as being normal. Based on these evaluations, a recommendation is made by the reader to either recall the participant for further assessment or return home to routine screening. If there is a discrepancy between the reader's interpretation and the CAD findings, another reader may be consulted to review the mammogram.
- Arm III (double reading followed by single reading with CAD): Screening mammograms are reviewed by double reading as in arm I followed by single reading with CAD as in arm II.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 30,000 participants will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- breast imaging study, comparison of screening methods, radiomammography
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast imaging studyProcedure or surgery
comparison of screening methodsProcedure or surgery
radiomammographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast cancer detection rate
Recall rate
Secondary outcomes (1)
Film reader performance using computer-aided detection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startSep 2006
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aberdeen Royal Infirmary
- Sponsor type
- University, hospital or other
- Investigators
- Fiona Gilbert, MD, Study chair, Aberdeen Royal Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450359
- Sponsor's protocol ID
- ABROIN-06-MRE01-14
- Other IDs
- CDR0000534404, CRUK-CADET-II, ABROIN-CADET-II, EU-20709
- Status last verified
- Oct 2008
- First submitted
- 20 Mar 2007
- Last updated
- 2 Aug 2013
- Results posted
- No
Publications
James JJ, Gilbert FJ, Wallis MG, Gillan MG, Astley SM, Boggis CR, Agbaje OF, Brentnall AR, Duffy SW. Mammographic features of breast cancers at single reading with computer-aided detection and at double reading in a large multicenter prospective trial of computer-aided detection: CADET II. Radiology. 2010 Aug;256(2):379-86. doi: 10.1148/radiol.10091899.
PubMed 20656831Gilbert FJ, Astley SM, Gillan MG, Agbaje OF, Wallis MG, James J, Boggis CR, Duffy SW; CADET II Group. Single reading with computer-aided detection for screening mammography. N Engl J Med. 2008 Oct 16;359(16):1675-84. doi: 10.1056/NEJMoa0803545. Epub 2008 Oct 1.
PubMed 18832239
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Computer Aided Detection (CAD) in the NHS Breast Screening Programme [CADET II]
- ClinicalTrials.gov ID
- NCT00450359
- Acronym / sponsor ID
- ABROIN-06-MRE01-14
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Aberdeen Royal InfirmaryUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: A computer-aided detection program may help doctors find breast cancer sooner, when it may be easier to treat, in women undergoing screening mammography.
PURPOSE: This randomized clinical trial is studying how well computer-aided breast cancer detection works in women undergoing screening mammography.
Detailed description
OBJECTIVES:
- Compare, prospectively, the breast cancer detection rate and recall rate of single reading using computer-aided detection vs standard double reading in women undergoing screening mammography.
OUTLINE: This is a prospective, randomized, multicenter study. Participants are randomized to 1 of 3 screening arms.
- Arm I (double reading): Screening mammograms are independently reviewed by two readers (i.e., radiologist or radiographer), each of whom reports on any abnormalities and decides whether a participant is recalled for further assessment or returned home to routine screening. In the event there is disagreement between the readers' findings, a third reader acts as an arbitrator by rendering an interpretation of the mammogram and making the final decision to recall the participant or return to routine screening.
- Arm II (single reading with computer-aided detection [CAD]): Screening mammograms are reviewed initially by a single reader who reports on any abnormalities. The reader then re-examines the mammogram with the aid of CAD, a system that uses computer prompts to recall suspicious features or abnormalities that may have been overlooked or previously dismissed as being normal. Based on these evaluations, a recommendation is made by the reader to either recall the participant for further assessment or return home to routine screening. If there is a discrepancy between the reader's interpretation and the CAD findings, another reader may be consulted to review the mammogram.
- Arm III (double reading followed by single reading with CAD): Screening mammograms are reviewed by double reading as in arm I followed by single reading with CAD as in arm II.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 30,000 participants will be accrued for this study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breast imaging study | Procedure or surgery | – |
| comparison of screening methods | Procedure or surgery | – |
| radiomammography | Procedure or surgery | – |
Primary outcome
Breast cancer detection rate
Recall rate
1 secondary outcome
Film reader performance using computer-aided detection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
- Results publication: PubMed 20656831James JJ, Gilbert FJ, Wallis MG, Gillan MG, Astley SM, Boggis CR, Agbaje OF, Brentnall AR, Duffy SW. Mammographic features of breast cancers at single reading with computer-aided detection and at double reading in a large multicenter prospective trial of computer-aided detection: CADET II. Radiology. 2010 Aug;256(2):379-86. doi: 10.1148/radiol.10091899.
- Results publication: PubMed 18832239Gilbert FJ, Astley SM, Gillan MG, Agbaje OF, Wallis MG, James J, Boggis CR, Duffy SW; CADET II Group. Single reading with computer-aided detection for screening mammography. N Engl J Med. 2008 Oct 16;359(16):1675-84. doi: 10.1056/NEJMoa0803545. Epub 2008 Oct 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Gilbert, MD study chair
Aberdeen Royal Infirmary
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breast imaging study, comparison of screening methods and radiomammography in people with Breast Cancer, run by Aberdeen Royal Infirmary at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast cancer detection rate. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00450359, which also lists 2 linked publications.
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 2 Aug 2013.