Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Koning Corporation
Age
35–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Female sex
Age 35 years or older
Any ethnicity
Have an abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE), or have an abnormality detected by an imaging modality.
Will undergo study imaging within four weeks from the date of diagnostic mammography, prior to breast biopsy (if needed).
Able to provide informed consent
Post-menopausal, surgically sterile, or effective birth control. For women of childbearing potential, negative pregnancy test or has signed pregnancy test waiver
If required by standard of care, eGFR \>45 within 48 hours to 6 weeks of CE-CBBCT exam
You may not be if
Pregnancy
Lactation
Unknown pregnancy status AND
has refused pregnancy testing and
has refused to sign a pregnancy test waiver
Women who are unable or unwilling to understand or to provide informed consent
Women 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.
Women who are unable to tolerate study constraints.
Women who have received radiation treatments to the thorax or breast area 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 Hodgkin's disease
* Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to):
Tuberculosis
Severe scoliosis
Allergic to iodinated contrast material
Previous non-ionic contrast reaction
Any conditions below regardless of eGFR
* Renal Disease
* Chronic renal dysfunction
* Renal Transplant (or waiting for a transplant)
* One kidney or other birth defect
* Polycystic Kidneys
* Renal Tumor/Renal Cancer
* History of liver failure/cirrhosis/liver transplant/pending liver transplant
* Congestive heart failure
* Multiple myeloma
* Hyperthyroidism
* Pheochromocytoma
* Sickle Cell Disease
Patient's body weight is over the limit of the scanner table (440 lbs or 200kg)
