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

Hologic

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Affirm Contrast Biopsy procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT04671329

20-03

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Affirm Contrast Biopsy

Other group

Description:

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

Treatment:

Device: Affirm Contrast Biopsy procedure