Evaluation of Breast CT

NCT ID: NCT00584233

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-22
• Study Completion Date: 2020-03-05

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

computed tomography

Intervention Type: 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).

MRI

Intervention Type: DEVICE

Breast MRI

Interventions

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).

Intervention Type: DEVICE

MRI

Breast MRI

Intervention Type: DEVICE

Other Intervention Names

Breast x-ray

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John M. Boone, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UC Davis Dept. of Radiology

Locations

UC Davis Medical Center

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01CA181081

Identifier Type: NIH

Identifier Source: secondary_id

View Link

214750

Identifier Type: -

Identifier Source: org_study_id