N/A
N=75
Evaluation of Breast CT
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00584233 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Comparison of Pre- and Post- Contrast Breast Computed Tomography With Pre- and Post- Contrast Magnetic Resonance Imaging. — -0.04 probability — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- computed tomography (Device); MRI (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- University of California, Davis
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Pre- and Post- Contrast Breast Computed Tomography With Pre- and Post- Contrast Magnetic Resonance Imaging. |
-0.04 | 0.05 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age at least 35 years old
- Diagnostic findings from prior mammography highly suggestive of breast malignancy (BI- RADS® category 4 or BI-RADS® category 5)
- Not pregnant or breast-feeding
- Ability to lie motionless for up to 5 minutes
Exclusion Criteria
- Recent breast biopsy
- History of moderate or severe reaction to contrast agent injection
- History of Allergy to Iodine
- History of multiple food and/or drug allergy
- Currently taking Glucophage or Glucovance (Metformin)
- History of Chronic Asthma
- History of Diabetes Mellitus
- Renal (kidney) disease, or solitary kidney
- Recent lab tests showing elevated serum creatinine (≥ 1.5 mg/dL)
- Recent lab tests showing estimated glomerular filtration rate (eGFR) ≤ 60 ml/minute
- Positive urine pregnancy test or currently breast-feeding
- Inability to understand the risks and benefits of the study
- The standard MRI contraindications apply, including but not limited to: having a pacemaker or other implanted electronic device, metal foreign bodies within the eye, aneurysm clips, heart valve prosthesis, vascular stents, coils, intrauterine devices (IUDs), inferior vena cava (IVC) filters, gunshot wounds with retained bullet fragments.
Data sourced from ClinicalTrials.gov (NCT00584233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.