N/A
N=67
A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04671329 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Number of Participants With Technical Success — 60 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Affirm Contrast Biopsy procedure (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Hologic, Inc.
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Technical Success |
60 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04671329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.