CESM ABMR Breast Cancer Screening Trial

Study Overview
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Brief Summary
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This is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast MRI which have been recommended for biopsy. Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard breast MRI, using the following performance measures: cancer detection rate (CDR), biopsy rate, and cancer yield of biopsy (also known as positive predictive value 3 or PPV3). Secondary Aims: Compare screening performance outcome measures of sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for CESM, ABMR, and standard breast MRI. This will determine the feasibility of each modality as an alternative to standard breast MRI and provide valuable pilot data for designing a larger clinical trial to evaluate non-inferiority of either or both modalities. Breast cancer characteristics (size, histologic subtype, node-positivity, AJCC stage) will be assessed in the overall cohort, and stratified by mode of detection for each modality(screen-detected versus interval).

Official Title
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Comparative Performance of Contrast-enhanced Spectral Mammography (CESM) and Abbreviated Breast MRI (ABMR) With Standard Breast MRI for Breast Cancer Screening

Conditions
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Breast Cancer Screening

Intervention / Treatment
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* Device: Contrast-enhanced Spectral Mammography (CESM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures; Women aged ≥18 years at the time of enrollment Referred clinically for breast MRI for any indication Exclusion Criteria: Known allergy or contraindication to iodinated contrast Are currently pregnant based on urine pregnancy test Have breast implants Are lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Asymptomatic women at increased risk of breast cancer referred clinically for high risk screening breast MRI or women with newly diagnosed primary unilateral breast cancer referred for evaluation of extent of disease (EOD) in the index breast and screening of the contralateral breast. All women enrolled on study will complete a clinical breast MRI and research contrast enhanced mammogram. Abbreviated MRI images will be extracted from the standard breast MRI exam. | Device: Contrast-enhanced Spectral Mammography (CESM)<br>* Dual energy mammography images obtained after the administration of an intravenous contrast agent<br>|
| Cohort 2<br>Women receiving MRI for any indication and for whom percutaneous biopsy with ultrasound or MRI guidance has been recommended. All women enrolled on study will complete a standard breast MRI and research contrast enhanced mammogram. Abbreviated MRI images will be extracted from the standard breast MRI exam. | Device: Contrast-enhanced Spectral Mammography (CESM)<br>* Dual energy mammography images obtained after the administration of an intravenous contrast agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal interpretation rate | Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy rate | Biopsy rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 2 years | 
| Positive predictive value for biopsy recommendation (PPV2) | Positive predictive value for biopsy recommendation (PPV2) will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 3 years | 
| Negative predictive value | Negative predictive value will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 3 years | 
| Cancer detection rate | Cancer detection rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 3 years | 
| Sensitivity | Sensitivity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 2 years | 
| Specificity | Specificity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI) | 2 years |