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

NCT ID: NCT04671329

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2022-08-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Affirm Contrast Biopsy

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

Group Type: OTHER

Affirm Contrast Biopsy procedure

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hologic, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic

Phoenix, Arizona, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

20-03

Identifier Type: -

Identifier Source: org_study_id