Cone Beam Computed Tomography for Breast Imaging

Study Overview
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Brief Summary
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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.

Official Title
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Cone Beam Computed Tomography for Breast Imaging and IV Contrast Enhanced Cone Beam Computed Tomography Breast Imaging

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Computed Tomography
* Radiation: Computed Tomography
* Radiation: Computed Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br> | Radiation: Computed Tomography<br>* 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.<br>|
| Experimental: Group II<br> | Radiation: Computed Tomography<br>* In Group II , at least fifty (50) study participants, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a breast CBCT specifically designed to image the breast.<br>|
| Experimental: Group III<br> | Radiation: Computed Tomography<br>* In Group III, at least 30 study subjects, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a unilateral intravenous (IV) CE CBCT of the involved breast.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, cone beam computed tomography