Breast Cancer
Conditions
Brief summary
Up to one hundred (100) female patients will be enrolled and consented to participate in the study. These women will be enrolled from screening assigned BIRADS 0, patient complaint, or referral for second opinion. The enrolled patient will accept CE-CBBCT scans within 4 weeks of her diagnostic mammography and before breast biopsy if biopsy is needed. The final diagnostic workup outcome of these enrolled patients needs to include at least 30 confirmed cancers cases.
Interventions
RADIATIONContrast Enhanced Cone Beam Breast CT Scan
* Pre-contrast scan * Begin contrast injection (and saline chaser) * Post-contrast Scan. Start time of post-contrast CE-CBBCT scan is 90-200 seconds after start of injection, depending on method of contrast delivery (bolus vs hand injection)
DRUGContrast Dye, Iodinated
1.5-2ml/kg body weight (100 ml maximum) of a low osmolar, nonionic, 300-350 mgI/ml iodinated contrast agent, will be injected at a rate of \ 2.0 ml/s, for a total injection time of 30-60 seconds (for a 50 kg subject). This will be immediately followed by a saline chaser from 20 to 40 ml at \ 2 ml/s (20 seconds) to maximize dynamic enhancement.
Sponsors
Koning Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Subjects in this group will be enrolled from screening assigned BIRADS 0, patient complaint, or referral for second opinion. The enrolled patient will accept CE-CBBCT scans within 4 weeks of her diagnostic mammography and before breast biopsy if biopsy is needed.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast lesions | Within 4 weeks after the imaging acquisition if finished if there is a suspicious finding in the images. | The existence of lesions in the breast |
Countries
United States
Outcome results
None listed