Skip to main content
OpenTrials
Completed

NCT Number: NCT00584233

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

computed tomography

Device

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 names: Breast x-ray

MRI

Device

Breast MRI

Primary outcomes

  1. Comparison of Pre- and Post- Contrast Breast Computed Tomography With Pre- and Post- Contrast Magnetic Resonance Imaging.

    Time frame: 5 years

    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).

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2004
Primary completion
2020
Study completion
2020
First posted
Jan 2, 2008
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.