Evaluation of Breast CT
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 35 - Any |
| Updated: | 1/6/2019 |
| Start Date: | December 2004 |
| End Date: | December 2019 |
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.
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.
Clinical evaluation: Four hundred women who will be having breast biopsy as part of their
standard care (BIRADS 4 and 5) will be recruited to undergo additional imaging prior to
biopsy, including (research) pre-and post-contrast enhanced breast CT imaging of both
breasts, as well as (standard, FDA approved) contrast enhanced breast MRI. The potential of
non-contrast enhanced breast CT will be compared using receiver operating characteristic
(ROC) methodology against mammography alone, as well as with mammography + tomosynthesis. The
breast CT images (including both pre-and post-contrast images) will be compared using ROC
methodology against standard-of-care contrast-enhanced MRI (which includes both non-contrast
and contrast images). The results of the clinical trials proposed in this investigation
should provide strong evidence in regards to the potential of breast CT for breast cancer
screening in the normal risk and high risk populations.
standard care (BIRADS 4 and 5) will be recruited to undergo additional imaging prior to
biopsy, including (research) pre-and post-contrast enhanced breast CT imaging of both
breasts, as well as (standard, FDA approved) contrast enhanced breast MRI. The potential of
non-contrast enhanced breast CT will be compared using receiver operating characteristic
(ROC) methodology against mammography alone, as well as with mammography + tomosynthesis. The
breast CT images (including both pre-and post-contrast images) will be compared using ROC
methodology against standard-of-care contrast-enhanced MRI (which includes both non-contrast
and contrast images). The results of the clinical trials proposed in this investigation
should provide strong evidence in regards to the potential of breast CT for breast cancer
screening in the normal risk and high risk populations.
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.
We found this trial at
1
site
Sacramento, California 95814
Principal Investigator: John M. Boone, Ph.D.
Phone: 916-734-3158
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