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

NCT04671329 | Completed Results FDA Device

• 1 other identifier: 20-03
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Breast Biopsy, Contrast Biopsy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Affirm Contrast Biopsy

OTHER

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

Interventions

Affirm Contrast Biopsy procedure DEVICE

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.

Affirm Contrast Biopsy

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (2)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

No limitations or caveats were found for this study. A total of 67 subjects were enrolled and seven subjects were withdrawn by the Investigator (did not complete the biopsy procedure), for a final total of 60 subjects who were included in the final analysis. The seven withdrawal cases were not related to any procedure failure but related to no lesion enhancement found or no biopsy needed.

Results Point of Contact

• Title: Muhammad Waqas, Director of Global Clinical Affairs
• Organization: Hologic, Inc.

ClinicalResearch@Hologic.com

(508) 826-7183

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 17, 2020
• Study Start: March 5, 2021
• Primary Completion: April 18, 2022
• Study Completion: August 18, 2022
• Last Updated: October 16, 2023
• Results First Posted: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)