Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)

November 30, 2012 updated by: Philips Healthcare

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Koln, Germany
        • Strahleninstitut CDT
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama
    • District of Columbia
      • Washington DC, District of Columbia, United States, 20037
        • George Washington Medical Faculty Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Screening and diagnostic mammography patients

Description

Inclusion Criteria:

  1. 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.
  2. At least 40 years of age
  3. Provides written informed consent indicating willingness to participate in this research study prior to performance of the Philips FFDM mammogram
  4. Meets none of the exclusion criteria

Exclusion Criteria:

  1. Presence of a breast implant,
  2. Patients undergoing a unilateral mammogram or an incomplete SF mammogram
  3. had previously undergone an excisional breast biopsy
  4. Pregnant women or patients who believe they may be pregnant

(f) Inmates (in accordance with 45 CFR 46.306)

(g) Patients who cannot, for any reason, undergo follow-up mammography examinations (where clinically indicated) at the participating institution

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
FFDM (Full Field Digital Mammography)
Mammograms from the Philips Digital System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Healthcare

Investigators

  • Study Chair: Linda Jalbert, Philips Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (ESTIMATE)

October 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMSDR-2008-002 & 2010-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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