NCT04671329

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Hologic, Inc. · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Affirm Contrast Biopsy procedure	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.

Timeline

• Start date: 2021-03-05
• Primary completion: 2022-04-18
• Completion: 2022-08-18
• First posted: 2020-12-17
• Last updated: 2023-10-16
• Results posted: 2023-10-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study