Evaluation of Breast CT

Breast Cancer Clinical Trial

Official title:

Evaluation of Breast CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584233
• Other study ID #: 214750
• Secondary ID: 1R01CA181081
• Status: Completed
• Phase: N/A
• Start date: November 22, 2004
• Est. completion date: March 5, 2020

Study information

• Verified date: November 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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).
• MRI
Breast MRI

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Pre- and Post- Contrast Breast Computed Tomography With Pre- and Post- Contrast Magnetic Resonance Imaging.	The specific quantitative endpoint of the analysis is the difference in area under the receiver operating characteristic curve (AUC) between contrast-enhanced breast CT (CE-bCT) and contrast-enhanced breast MRI (CE-bMRI).	5 years