Evaluation of Breast CT
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Breast CT|
- Comparison of pre- and post- contrast breast computed tomography with pre- and post- contrast magnetic resonance imaging. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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.
Radiation: 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584233
|United States, California|
|UC Davis Medical Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: John M. Boone, Ph.D. 916-734-3158 firstname.lastname@example.org|
|Principal Investigator: John M. Boone, Ph.D.|
|Principal Investigator:||John M. Boone, Ph.D.||UC Davis Dept. of Radiology|