Breast Cancer
Conditions
Keywords
breast cancer, cone beam computed tomography
Brief summary
The primary aim of this study is to investigate the use of cone beam computed tomography (CBCT) for breast imaging in the diagnostic setting by providing a compelling body of evidence incorporating both non-contrast and contrast enhanced 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
RADIATIONComputed Tomography
In Group I, twelve 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
Koning Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Group I: * Are at least 40 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: * Are at least 40 years of age of any ethnicity * Had a routine mammogram, read as BI-RADS® 4 or 5 * Are scheduled for breast biopsy * Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy. * Is able to undergo informed consent. Group III: * Are at least 40 years of age of any ethnicity * Had a routine mammogram, read as BI-RADS® 4 or 5 * Are scheduled for breast biopsy * Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy. * 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 Group III: * 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 * Allergy or previous reaction to iodinated contrast material * History of renal dysfunction/kidney disease * Long standing diabetes mellitus * Multiple myeloma * Dehydration * History of nephrotoxic medication use * Hyperthyroidism * Diabetic patients on Metformin * Pheochromocytoma * Sickle Cell Disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study's intent is to provide compelling data to illustrate the potential contribution of CBCT for breast imaging, not to generate statistically significant data. | 3 years |
Countries
United States
Outcome results
None listed