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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT00999596
First received: October 21, 2009
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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.


Condition Phase
Breast Cancer
Phase 3

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Image Evaluation Study for Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)

Resource links provided by NLM:


Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • FFDM (Full Field Digital Mammography) Mammogram Scores [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 107
Study Start Date: April 2010
Study Completion Date: September 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
FFDM (Full Field Digital Mammography)
Mammograms from the Philips Digital System

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
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Screening and diagnostic mammography patients

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999596

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249
United States, District of Columbia
George Washington Medical Faculty Associates
Washington DC, District of Columbia, United States, 20037
Germany
Strahleninstitut CDT
Koln, Germany
Sponsors and Collaborators
Philips Healthcare
Investigators
Study Chair: Linda Jalbert Philips Healthcare
  More Information

No publications provided

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT00999596     History of Changes
Other Study ID Numbers: PMSDR-2008-002 & 2010-002
Study First Received: October 21, 2009
Results First Received: June 14, 2011
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Philips Healthcare:
Breast Cancer
Digital Mammography

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

ClinicalTrials.gov processed this record on September 14, 2014