Cone Beam Computed Tomography for Breast Imaging

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Cone Beam Computed Tomography for Breast Imaging

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Computed Tomography
* Device: Computed Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br> | Device: Computed Tomography<br>* 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.<br>|
| Group II<br> | Device: Computed Tomography<br>* 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.<br>|

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 |