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Cone Beam Computed Tomography for Breast Imaging


Phase 2
35 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Cone Beam Computed Tomography for Breast Imaging


Inclusion Criteria:



Group I:

- Females at least 35 years of age of any ethnicity

- Had a mammogram, read as BI-RADSĀ® 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

about 3 years

Safety Issue:

Yes

Principal Investigator

Posy Seifert, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Elizabeth Wende Breast Care, LLC

Authority:

United States: Institutional Review Board

Study ID:

KBCT-003

NCT ID:

NCT01107860

Start Date:

January 2010

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Elizabeth Wende Breast CareRochester, New York  14620