Evaluation of Breast CT
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|ClinicalTrials.gov Identifier: NCT00584233|
Recruitment Status : Active, not recruiting
First Posted : January 2, 2008
Last Update Posted : June 12, 2018
The investigators have studied the potential of breast computed tomography (bCT) for breast imaging under an NIH-funded Biomedical Research Partnership (BRP) grant (R01 EB002138-10), and 4 breast CT scanners have been developed that have imaged over 600 women to date (under more than one IRB-approved protocol). The BRP grant cannot be renewed, and with this (resubmitted) R01 grant application, the investigators seek to finalize the investigators' research in breast CT - The specific aims have been significantly modified as a result of the first critique, and the investigators now focus on a narrower set of remaining issues.
This version of the protocol will add breast magnetic resonance imaging (MRI) to the experimental procedures.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: computed tomography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Breast CT|
|Study Start Date :||December 2004|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Breast CT and Breast MRI
Four hundred women who will be having breast biopsy as part of their standard care (BIRADS 4 and 5) will undergo pre- and post- contrast breast computed tomography and pre- and post- contrast magnetic resonance imaging.
Device: computed tomography
Computed tomography of both breasts. For all subjects, CT scanning will be performed before and after an I.V. iodinated contrast injection (100 mL).
Other Name: Breast x-ray
- Comparison of pre- and post- contrast breast computed tomography with pre- and post- contrast magnetic resonance imaging. [ Time Frame: 5 years ]
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): NCT00584233
|United States, California|
|UC Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||John M. Boone, Ph.D.||UC Davis Dept. of Radiology|