Breast CancerNCT00999596
Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
An observational study of Breast Cancer, run by Philips Healthcare at 3 sites in 2 countries.
Trial summary
The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or diagnostic mammography. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 107 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2010to Sep 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Screening and diagnostic mammography patients
Who may be able to join
- Patient underwent or is scheduled to undergo a screening or diagnostic mammogram examination (right and left craniocaudal and mediolateral oblique with or without special views) at one of the acquisition centers during the course of this research study.
- At least 40 years of age
- Provides written informed consent indicating willingness to participate in this research study prior to performance of the Philips FFDM mammogram
- Meets none of the exclusion criteria
Who cannot join
- Presence of a breast implant,
- Patients undergoing a unilateral mammogram or an incomplete SF mammogram
- had previously undergone an excisional breast biopsy
- Pregnant women or patients who believe they may be pregnant
- Inmates (in accordance with 45 CFR 46.306)
- Patients who cannot, for any reason, undergo follow-up mammography examinations (where clinically indicated) at the participating institution
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Alabama
Birmingham, Alabama, 35249
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: Clinical Image Evaluation Study for Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or diagnostic mammography.
Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no longer required.
Read the detailed description
The proposed research study is a prospective enriched reader trial in which patients who meet the study's eligibility criteria, subject to certain constraints specified in this protocol, will undergo both SF and the investigational Philips FFDM mammography. Two to five sites will participate as image acquisition centers. Images will be read by 9 mammographers reading the SF and Philips FFDM acquired images at various locations under the supervision of study managers.
Per the new FDA Guidance document for FFDM (Class II Special Controls Guidance Document: Full-Field Digital Mammography System), there is no longer a requirement for screen film images for a comparison and a reader study to determine accuracy is not required. 10 images acquired under protocols 2008-002a, 2010-002a and a European site will be read in a MQSA type study. This record has been modified to support the new FDA Guidance document.
The reviewers will evaluate the cases, using soft copy and hard copy images, noting the mammographic attributes for each case and documenting the findings on a clinical image evaluation form, which is very similar to what is used for MQSA Accreditation.
The following attributes will be assessed: in order to provide an overall assessment of whether these image sets collectively are of sufficient acceptable quality for mammography:
- Breast positioning, assessing coverage of the breast on craniocaudal(CC) and medio-lateral oblique (MLO) views, separately;
- Exposure, assessing visualization of the adipose and fibroglandular tissues and visualization of breast tissue underlying the pectoralis muscle, separately;
- Breast compression, assessing overlapping breast structures, uniformity of exposure of fibroglandular tissues, adequacy of penetration of thicker portions of the breast, exposure of thinner areas, and motion unsharpness;
- Image contrast for differentiation of subtle tissue density differences;
- Sharpness, assessing the edges of fine linear structures and tissues;
- Borders and benign calcifications;
- Tissue visibility at the skin line;
- Noise, i.e., noise obscuring breast structures or suggestive of structures not actually present;
- Artifacts due to image processing, detector failure and other factors external to the breast on hard-copy and soft-copy displays; and
- Overall clinical image quality
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Digital Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FFDM (Full Field Digital Mammography) | Mammograms from the Philips Digital System |
What is being measured
The primary outcome is the main question the study is designed to answer.
FFDM (Full Field Digital Mammography) Mammogram Scores
6 mammography image sets (4 images per set) from women participating in the study were read and rated (pass/fail) by 2 MQSA (Mammorgraphy Quality Standards Act) certified mammography readers. A typical MQSA evaluation was performed on each image set and an image set was scored Pass or Fail. A total of 12 scores (6 image sets, 2 readers) were obtained.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startApr 2010
- Primary completionJan 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Jalbert, Study chair, Philips Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999596
- Sponsor's protocol ID
- PMSDR-2008-002 & 2010-002
- Status last verified
- Nov 2012
- First submitted
- 21 Oct 2009
- Last updated
- 4 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Image Evaluation Study for Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
- ClinicalTrials.gov ID
- NCT00999596
- Acronym / sponsor ID
- PMSDR-2008-002 & 2010-002
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Digital Mammography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Posted 2 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or diagnostic mammography.
Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no longer required.
Detailed description
The proposed research study is a prospective enriched reader trial in which patients who meet the study's eligibility criteria, subject to certain constraints specified in this protocol, will undergo both SF and the investigational Philips FFDM mammography. Two to five sites will participate as image acquisition centers. Images will be read by 9 mammographers reading the SF and Philips FFDM acquired images at various locations under the supervision of study managers.
Per the new FDA Guidance document for FFDM (Class II Special Controls Guidance Document: Full-Field Digital Mammography System), there is no longer a requirement for screen film images for a comparison and a reader study to determine accuracy is not required. 10 images acquired under protocols 2008-002a, 2010-002a and a European site will be read in a MQSA type study. This record has been modified to support the new FDA Guidance document.
The reviewers will evaluate the cases, using soft copy and hard copy images, noting the mammographic attributes for each case and documenting the findings on a clinical image evaluation form, which is very similar to what is used for MQSA Accreditation.
The following attributes will be assessed: in order to provide an overall assessment of whether these image sets collectively are of sufficient acceptable quality for mammography:
- Breast positioning, assessing coverage of the breast on craniocaudal(CC) and medio-lateral oblique (MLO) views, separately;
- Exposure, assessing visualization of the adipose and fibroglandular tissues and visualization of breast tissue underlying the pectoralis muscle, separately;
- Breast compression, assessing overlapping breast structures, uniformity of exposure of fibroglandular tissues, adequacy of penetration of thicker portions of the breast, exposure of thinner areas, and motion unsharpness;
- Image contrast for differentiation of subtle tissue density differences;
- Sharpness, assessing the edges of fine linear structures and tissues;
- Borders and benign calcifications;
- Tissue visibility at the skin line;
- Noise, i.e., noise obscuring breast structures or suggestive of structures not actually present;
- Artifacts due to image processing, detector failure and other factors external to the breast on hard-copy and soft-copy displays; and
- Overall clinical image quality
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFDM (Full Field Digital Mammography) | – | –Mammograms from the Philips Digital System |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Screening and diagnostic mammography patients
Key inclusion criteria (4 listed)
- Patient underwent or is scheduled to undergo a screening or diagnostic mammogram examination (right and left craniocaudal and mediolateral oblique with or without special views) at one of the acquisition centers during the course of this research study.
- At least 40 years of age
- Provides written informed consent indicating willingness to participate in this research study prior to performance of the Philips FFDM mammogram
- Meets none of the exclusion criteria
Key exclusion criteria (6 listed)
- Presence of a breast implant,
- Patients undergoing a unilateral mammogram or an incomplete SF mammogram
- had previously undergone an excisional breast biopsy
- Pregnant women or patients who believe they may be pregnant
- Inmates (in accordance with 45 CFR 46.306)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FFDM (Full Field Digital Mammography) Mammogram Scores
Time frame: Day 1
6 mammography image sets (4 images per set) from women participating in the study were read and rated (pass/fail) by 2 MQSA (Mammorgraphy Quality Standards Act) certified mammography readers. A typical MQSA evaluation was performed on each image set and an image set was scored Pass or Fail. A total of 12 scores (6 image sets, 2 readers) were obtained.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Linda Jalbert study chair
Philips Healthcare
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Philips Healthcare at 3 sites in 2 countries.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany. 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?
Yes. Results are posted in the registry (first posted 2 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
FFDM (Full Field Digital Mammography) Mammogram Scores (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2012.