NCT00584233

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2020

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

December 6, 2022

Completed
Last Updated

December 6, 2022

Status Verified

November 1, 2022

Enrollment Period

15.3 years

First QC Date

December 21, 2007

Results QC Date

September 27, 2022

Last Update Submit

November 10, 2022

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Breast CT and Breast MRI

EXPERIMENTAL

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.

Device: computed tomographyDevice: MRI

Interventions

computed tomographyDEVICE

Computed tomography of both breasts. For all subjects, CT scanning will be performed before and after an I.V. iodinated contrast injection (100 mL).

Also known as: Breast x-ray
Breast CT and Breast MRI
MRIDEVICE

Breast MRI

Breast CT and Breast MRI

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tomography, X-Ray ComputedMammography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Results Point of Contact

Title
Dr. John Boone
Organization
University of California Davis
jmboone@ucdavis.edu
(916) 849-3580

Study Officials

  • John M. Boone, Ph.D.

    UC Davis Dept. of Radiology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 2, 2008

Study Start

November 22, 2004

Primary Completion

March 5, 2020

Study Completion

March 5, 2020

Last Updated

December 6, 2022

Results First Posted

December 6, 2022

Record last verified: 2022-11

Locations

US(1)