Breast Cancer
Conditions
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.
Interventions
DEVICEComputed 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.
Sponsors
Elizabeth Wende Breast Care, LLC
National Cancer Institute (NCI)
Koning Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology | 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 |
Countries
United States
Outcome results
None listed