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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671329
• Other study ID #: 20-03
• Status: Completed
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: August 18, 2022

Study information

• Verified date: October 2023
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 18, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)