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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Affirm Contrast Biopsy procedure

• Registration Number: NCT04671329
• Lead Sponsor: Hologic, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-17
• Study Start: 2021-03-05
• Primary Completion: 2022-04-18
• Study Completion: 2022-08-18
• Results First Submitted: 2023-06-21
• Results First Submitted QC: 2023-09-11
• Status Verified: 2023-10
• Results First Posted: 2023-10-05
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Affirm Contrast Biopsy	Affirm Contrast Biopsy procedure	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Technical Success	Up to 1h (time to complete the procedure)	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).

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States