A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy

Study Overview
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Brief Summary
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Currently, if a radiologist finds a suspicious lesion seen only on a diagnostic Contrast Enhanced Digital Mammography (CEDM) exam requiring biopsy the biopsy procedure would likely be performed with MRI guidance because there are currently limited solutions to biopsy with CEDM guidance. Affirm Contrast Biopsy will provide an additional solution to biopsy/localize lesions found by using a CEDM imaging modality.

Official Title
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A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Affirm Contrast Biopsy procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females aged 40 years of age or older recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities Subject is able to read, understand, and sign the study specific informed consent form after the nature of the study has been fully explained to them Exclusion Criteria: Subjects who require a Legally Authorized Representative (LAR) for Informed Consent Subjects who, based on the physician's judgement, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders Subjects who have had a previous allergic reaction to IV contrast agent

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Affirm Contrast Biopsy<br>Women 40 years of age or older recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities | Device: Affirm Contrast Biopsy procedure<br>* Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system and 3Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Technical Success | Technical success was defined as successfully completing the breast biopsy procedure with the Affirm Contrast Biopsy system for each participant (60 participants equals 60 procedures). | Up to 1h (time to complete the procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Biopsy, Contrast Biopsy