CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
Affirm Contrast Biopsy proceduredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04671329
NCT04671329N/ACompleted
CompareCT.gov

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

Hologic, Inc.·interventional·Posted Dec 17, 2020·Updated Oct 16, 2023

In Brief

A clinical study evaluating Affirm Contrast Biopsy procedure for Breast Cancer. Completed, enrolled 67 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 17, 2020
Enrollment StartMar 5, 2021
Primary CompletionApr 18, 2022
Study CompletionAug 18, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.5 years ago

Interventions

Affirm Contrast Biopsy proceduredevice

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.