Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cone Beam Computed Tomography for Breast Imaging

This study has been completed.
Elizabeth Wende Breast Care
Information provided by (Responsible Party):
Koning Corporation Identifier:
First received: January 5, 2010
Last updated: June 14, 2013
Last verified: June 2013

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.

Condition Intervention Phase
Breast Cancer
Device: Computed Tomography
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cone Beam Computed Tomography for Breast Imaging

Resource links provided by NLM:

Further study details as provided by Koning Corporation:

Primary Outcome Measures:
  • Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology [ Time Frame: about 3 years ] [ Designated as safety issue: Yes ]

    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

Enrollment: 401
Study Start Date: January 2010
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Group II 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.


Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.


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
  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 identifier: NCT01107860

United States, New York
Elizabeth Wende Breast Care
Rochester, New York, United States, 14620
Sponsors and Collaborators
Koning Corporation
Elizabeth Wende Breast Care
Principal Investigator: Posy Seifert, D.O. Elizabeth Wende Breast Care, LLC
  More Information

No publications provided

Responsible Party: Koning Corporation Identifier: NCT01107860     History of Changes
Other Study ID Numbers: KBCT-003, 2R44CA103236-05A1
Study First Received: January 5, 2010
Last Updated: June 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on February 26, 2015