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Completed

NCT Number: NCT01107860

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

35 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Elizabeth Wende Breast Care

Rochester, New York, 14620, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

computed tomography

Device

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.

Primary outcomes

  1. Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology

    Time frame: about 3 years

    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

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Sponsors and collaborators

Lead sponsor

Koning Corporation

Industry

Collaborators

  • Elizabeth Wende Breast Care, LLC
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Apr 21, 2010
Registry last updated
Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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