Breast Computed Tomography (CT) as a Diagnostic Tool

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ioannis Sechopoulos, Ph.D., Emory University
ClinicalTrials.gov Identifier:
NCT00957307
First received: August 11, 2009
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

Lay Summary

The American Cancer Society has recommended that all women over the age of 40 have an annual mammogram for many years. This recommendation has been associated with a substantial decrease in breast cancer deaths. When something suspicious is seen in one of these mammograms, the woman is called back to the clinic for more imaging tests to better determine if that suspicious feature might be breast cancer. These additional imaging tests include repeated mammograms, magnification mammograms and/or ultrasound. Depending on what is seen in these images, the radiologist will provide a diagnosis that the suspicion is probably cancer, probably benign, or that the suspicion is a "false alarm." If it is a false alarm, then the woman is sent home and she should come back after a year for another standard annual mammogram. If the diagnosis is that it is probably benign, then the woman should come back after 6 months so that the suspicion can be tested again. If the diagnosis is that it is probably cancer, the woman is recommended to have a biopsy so that the cancer can be confirmed. Both fortunately and unfortunately, 80% of the biopsies turn out to be "false alarms." Although confirming that a woman does not have cancer is always a very good thing, having put her through the anxiety, expense, and risk of a biopsy for what turned out to be nothing should be avoided. Therefore, it would be desirable to reduce the number of unnecessary biopsies that are performed.

Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. The investigators propose to use breast CT as a new, better tool for the radiologist to perform the diagnosis, and therefore hopefully result in fewer biopsies, which should decrease the "false alarms." Before breast CT can be used clinically as a diagnostic tool, extensive testing must be performed. In this first step, the investigators propose to acquire breast CT images of only 10 patients that have been recommended to have biopsies, to see if the radiologist would have arrived at a different diagnosis if he/she had based his/her decision on the breast CT images. Since this has never been attempted before, this is an initial small study to test the feasibility of this method.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Breast CT as a Diagnostic Tool

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Reduction in negative biopsies [ Time Frame: After biopsy ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: May 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

See Brief Summary

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women having breast biopsy for either masses or calcifications

Criteria

Inclusion Criteria:

  • All subjects will be women at least 35 years of age that have been found, after diagnostic workup, to have focal distributions of microcalcifications (BI-RADS 4 or 5) or focal soft tissue lesions (BI-RADS 4 or 5)

Exclusion Criteria:

  • Subject does not meet any of the inclusion criteria
  • Women with suspected or confirmed pregnancy
  • Women who have had bilateral mastectomy
  • Women who are very frail and unable to cooperate
  • Women who are under 35 years of age
  • Women who cannot give informed consent
  • Male subjects
  • Women with implants
  • Subject has had breast augmentation, except for unilateral augmentation done for prior mastectomy
  • Women recalled for bilateral workup
  • Women with physical limitations such as, but not limited to: frozen shoulder, recent heart surgery, pace maker, neck problems, or any other condition that would prohibit them from lying face down
  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: NCT00957307

Locations
United States, Georgia
Emory University Hospital Breast Imaging Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Ioannis Sechopoulos, PhD Emory University
  More Information

No publications provided

Responsible Party: Ioannis Sechopoulos, Ph.D., Assistant Professor of Radiology and Imaging Sciences, Emory University
ClinicalTrials.gov Identifier: NCT00957307     History of Changes
Other Study ID Numbers: IRB00014006
Study First Received: August 11, 2009
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014