Status:
COMPLETED
A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy
Lead Sponsor:
Hologic, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
NA
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 M...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04671329
Start Date
March 5 2021
End Date
August 18 2022
Last Update
October 16 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213