Evaluation of Breast CT

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of California, Davis
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John M. Boone, PhD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584233
First received: December 21, 2007
Last updated: December 18, 2015
Last verified: December 2015
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: computed tomography
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Breast CT

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
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)
Arms Assigned Interventions
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

Detailed 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.
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584233

Locations
United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: John M. Boone, Ph.D.    916-734-3158    jmboone@ucdavis.edu   
Principal Investigator: John M. Boone, Ph.D.         
Sponsors and Collaborators
University of California, Davis
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: John M. Boone, Ph.D. UC Davis Dept. of Radiology
  More Information

Responsible Party: John M. Boone, PhD, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00584233     History of Changes
Other Study ID Numbers: 214750  1R01CA181081 
Study First Received: December 21, 2007
Last Updated: December 18, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Davis:
breast cancer

ClinicalTrials.gov processed this record on May 26, 2016