An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall

This study has been completed.
Sponsor:
Collaborator:
BBN Technologies
Information provided by (Responsible Party):
Carl J. D'Orsi, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00208871
First received: September 13, 2005
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

The primary goal of this study is to compare, within a clinical screening setting, the performance of stereoscopic digital mammography with standard (non-stereo) digital mammography in the detection of abnormalities in the breast, including early breast cancer.


Condition Intervention
Breast Cancer
Procedure: Stereoscopic Digital Mammography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • sensitivity/specificity [ Time Frame: Aug '04 to Dec '07 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recall rate [ Time Frame: Aug '04 to December '7 ] [ Designated as safety issue: No ]

Enrollment: 1467
Study Start Date: December 2004
Study Completion Date: March 2011
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Stereoscopic Digital Mammography
    screening digital 3D mammogram
Detailed Description:

The clinical trial, begun in December, 2004, is being conducted at Emory University. Over the next three years, we will enroll and image about 2000 women who are at elevated risk for development of breast cancer (personal or family history of breast cancer) as they come in for their annual screening examinations. Each participating patient will be imaged with both systems, and the stereo and standard (non-stereo) images will be read independently by different mammographers.

A stereoscopic digital mammogram consists of two x-ray images of the breast acquired from slightly different points of view on a digital mammography unit. The x-ray source is rotated 10-degrees between the two exposures while the position of the breast remains fixed in the compression device. The stereo pair of mammograms is viewed on a new third-generation, high-resolution stereo display workstation that was developed in the first part of this project. The mammographer views the stereo display wearing lightweight polarized glasses, enabling him or her to see in depth the internal structure within the breast. As a result, a subtle lesion that may be obscured by superimposed normal tissue in a standard 2D image, now becomes visible as the overlying and underlying normal tissue is separated in depth. Conversely, layers of tissue that may falsely resemble a lesion in a standard 2D image due to chance superimposition, are seen in the stereo mammogram to lie at different depths and, thus, will not be mistaken as a lesion.

We anticipate that with stereo mammography the mammographers will detect subtle lesions in the stereo images that are missed in the non-stereo images. We also expect that there will be fewer false positive detections with the stereo images compared to the standard images. Finally, we also expect that the mammographers will be more confident in their judgments of what they see in the stereo images, resulting in a reduced rate of recall of patients for further work-up.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Personal risk factors (any of the following)

  • Personal history of breast and/or ovarian cancer, regardless of age.
  • Prior breast biopsy that included any of the following high risk, benign lesion: Lobular carcinoma in-situ, Atypical ductal hyperplasia, Atypical lobular hyperplasia, Atypical columnar hyperplasia.
  • Positive test for known mutations of BRCA 1 or 2 genes, regardless of age.
  • History of chest irradiation for treatment of non-breast disease (EX:lymphoma, lung cancer) at least 15 years prior to enrollment.

Family history (over 30 years of age with any of the following, some exceptions may appy)

  • Ashkenazi Jewish ancestry, regardless of age.
  • Any history of male breast cancer on the maternal or paternal side.
  • Breast and ovarian cancer in a close relative (mother, sister, daughter)
  • Breast or ovarian cancer in more than one close relative (mother,sister daughter)
  • Breast cancer in a close relative (mother, sister, daughter) with early onset(<50 years of age)
  • Breast and ovarian cancer in a 2nd. degree relative (grandmother, aunt, niece) with early onset of breast cancer. (<50 years of age)
  • Multiple history of breast cancer in 1st. and 2nd. degree relatives.

Exclusion Criteria:

  • Patient does not meet any of the inclusion criteria,
  • Patient has had breast augmentation, except for unilateral augmentation done for prior mastectomy,
  • Patient has suspected or confirmed pregnancy,
  • Patient has large breasts that cannot be adequately imaged on the 19 x 23 cm detector surface of the GE Senographe 2000D digital mammography unit.
  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: NCT00208871

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
BBN Technologies
Investigators
Principal Investigator: David J Getty, Ph.D. BBN Technologies
Principal Investigator: Carl J D'Orsi, MD Emory School of Medicine Site PI
  More Information

Additional Information:
Publications:
Getty, D. J. Stereoscopic digital mammography: perceptual and display factors leading to improved early detection of breast cancer. In H-O Peitgen (Ed.), Digital Mammography, IWDM 2002, 6th International Workshop on Digital Mammography. Berlin: Springer, 2003, 431-435.
Getty DJ, Pickett RM, D'Orsi CJ. Stereoscopic digital mammography: improving detection and diagnosis of breast cancer. In: Computer Assisted Radiology and Surgery (CARS-2001). Berlin, Germany: Elsevier Science B.V., 2001.
Getty D. J. Stereoscopic digital mammography. Proceedings of the First Americas Display Engineering and Applications Conference (ADEAC '04), Ft. Worth, 2004, 11-14.
Getty, D. J. Stereoscopic and biplane digital radiography. In E. Samei & M. Flynn (Eds.), RSNA Categorical Course in Diagnostic Radiology Physics: Advances in Digital Radiography. RSNA Publications, 2003; 199-209.

Responsible Party: Carl J. D'Orsi, MD, Proffessor of Radiology & Hematology/Oncology, Emory University
ClinicalTrials.gov Identifier: NCT00208871     History of Changes
Other Study ID Numbers: IRB00045816
Study First Received: September 13, 2005
Last Updated: November 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Emory University:
Stereoscopic digital mammography
Breast cancer detection
Reduced rate of recall
Focal abnormalities detection

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

ClinicalTrials.gov processed this record on October 23, 2014