Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging

Study Overview
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Brief Summary
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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.

Official Title
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Contrast-Enhanced Cone Beam Breast CT for Diagnostic Breast Imaging

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Contrast Enhanced Cone Beam Breast CT Scan
* Drug: Contrast Dye, Iodinated


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria Due To Contrast Injection: 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 Asthma requiring daily use of inhaler Additional exclusion criteria due to machine limitations Patient's body weight is over the limit of the scanner table (440 lbs or 200kg)

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic Workup<br>The subjects will first have a pre-contrast CBBCT scan. Iodinated contrast will be injected intravenously, and then another CBBCT scans will be performed to capture the tumor vasculature enhancement. | Radiation: Contrast Enhanced Cone Beam Breast CT Scan<br>* 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)<br>Drug: Contrast Dye, Iodinated<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast lesions | The existence of lesions in the breast | Within 4 weeks after the imaging acquisition if finished if there is a suspicious finding in the images. |