Cone Beam Computed Tomography for Breast Imaging

The primary aim of this study is to continue the investigation of cone beam computed tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing a compelling body of evidence incorporating non-contrast CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Computed Tomography; Device: Computed Tomography

• Study Type: Observational
• Enrollment (Actual): 401

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • Elizabeth Wende Breast Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected from the patient population at a community based clinic, Elizabeth Wende Breast Care, LLC, which is located in Rochester, NY. Group I will consist of subjects who have had mammograms read as BIRADS® 1 or 2. Group II will be subjects who have had a diagnostic mammogram read as BIRADS® 4 or 5 prior to breast biopsy.

Description

Inclusion Criteria:

Group I:

• Females at least 35 years of age of any ethnicity
• Had a mammogram, read as BI-RADS® 1 or 2
• Will undergo study imaging no later than four weeks from date of mammogram.
• Is able to undergo informed consent.

Group II:

• Females at least 35 years of age of any ethnicity
• Require diagnostic imaging
• Will undergo study imaging no later than four weeks from date of diagnostic mammogram
• Is able to undergo informed consent

Exclusion Criteria:

Group I and Group II:

• Pregnancy
• Lactation
• Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
• Subjects who are unable to tolerate study constraints.

• Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)

  • Treatment for enlarged thymus gland as an infant
  • Irradiation for benign breast conditions, including breast inflammation after giving birth
  • Treatment for Hodgkins disease
• Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.

• Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

  • Tuberculosis
  • Severe scoliosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I	Device: Computed Tomography; In Group I, fifty CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.; Device: Computed Tomography; In Group II , at least three hundred and fifty (350) study participants, who require diagnostic evaluation of the breast will undergo a breast CBCT . These subjects may be referred for biopsy as a result of a finding from a mammogram, ultrasound, MRI, or clinical exam.
Group II	Device: Computed Tomography; In Group I, fifty CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.; Device: Computed Tomography; In Group II , at least three hundred and fifty (350) study participants, who require diagnostic evaluation of the breast will undergo a breast CBCT . These subjects may be referred for biopsy as a result of a finding from a mammogram, ultrasound, MRI, or clinical exam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology	The primary measure of this study will include the following aspects.; the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam; patient's comfort during the CBCT exam vs the mammographic exam; the concordance and discordance of CBCT breast imaging with standard mammography and other breast-imaging studies; the concordance and discordance of CBCT breast imaging with histopathology; number of participants with adverse events as a measure of safety	about 3 years

Collaborators and Investigators

• Sponsor: Koning Corporation
• Collaborators: National Cancer Institute (NCI); Elizabeth Wende Breast Care, LLC
• Investigators: Principal Investigator: Posy Seifert, D.O., Elizabeth Wende Breast Care, LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (ESTIMATE): April 21, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 18, 2013
• Last Update Submitted That Met QC Criteria: June 14, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: KBCT-003; 2R44CA103236-05A1 (NIH)