Cone Beam CT for Breast Imaging
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|ClinicalTrials.gov Identifier: NCT01880580|
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : June 19, 2013
|Condition or disease|
|Breast Imaging Breast Cancer|
|Study Type :||Observational|
|Actual Enrollment :||76 participants|
|Official Title:||Cone Beam CT for Breast Imaging: A Pilot Study|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
In Group I, up to 100 women, at least 40 years of age, who have had a routine standard mammogram read as BI-RADS® 0, 1, 2, or 3 will also undergo 3D breast imaging using a cone beam CT scanner specifically designed to image the breast. Of these 100, we hope to enroll at least 30 subjects with mammograms read as BI-RADS® 0 and at least 30 read as BI-RADS® 3. The BI-RADS® 0 category refers to patients for whom additional imaging is required after a screening mammogram provided incomplete diagnostic information.
The goals of Group II will be to compare the CBCT study with standard imaging for the diagnosis of breast disease in palpable or non-palpable breast lesions (having a BI-RADS® score of 4 or 5). Forty (40) women, who have had abnormalities detected by physical exam or an imaging modality and are also scheduled for breast biopsy of the index lesion, will also undergo a CBCT of the breast(s), prior to biopsy.
- Image Quality of Cone Beam Breast CT [ Time Frame: 6 years ]This study was to evaluate the radiation dose, breast coverage, and image quality of cone-beam breast CT compared with a conventional mammographic examination.
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): NCT01880580
|United States, New York|
|University of Rochester Highland Breast Imaging Center|
|Rochester, New York, United States, 14620|