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Breast Computed Tomography (CT) as a Diagnostic Tool

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00957307
First Posted: August 12, 2009
Last Update Posted: July 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ioannis Sechopoulos, Ph.D., Emory University
  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 Ioannis Sechopoulos, Ph.D., Emory University:

Primary Outcome Measures:
  • Reduction in negative biopsies [ Time Frame: After biopsy ]

Enrollment: 16
Study Start Date: May 2009
Study Completion Date: January 2015
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:
See Brief Summary
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 11, 2009
First Posted: August 12, 2009
Last Update Posted: July 23, 2015
Last Verified: July 2015