Status:
ACTIVE_NOT_RECRUITING
Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Bracco Corporate
Conditions:
Breast Benign Tumor
Breast Malignant Tumor
Eligibility:
FEMALE
18-99 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the ability of AI to correctly aid in characterization of benign and malignant lesions even when a low dose of gadolinium is administered. This study is releva...
Detailed Description
The study involves each patient presenting for an initial MRI with a regular dose of gadolinium and then presenting at least 48 hours after (no less than 14 days later) for a ¼ dose (see below regardi...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Breast Cancer Patients:
- Female patient between ≥ 18 years old and ≤ 99 years old
- Patients with newly diagnosed primary breast cancer
- Patient able and willing to participate in the trial
- Inclusion criteria for Non-malignant indications:
- Female patients between ≥ 18 years old and ≤ 99 years old
- Be referred for MRI for non-malignant indications (screening or BIRADS 3)
- Patients have had prior exam with known enhancing mass, nonmass enhancement, or focus/foci.
- Exclusion Criteria:
- Non-female patients
- Patients \< 18 years old
- Women who are lactating or pregnant
- Patients with recurrent breast cancer
- Patients who have already received neoadjuvant chemotherapy
- Unable to lie still on the imaging table for one (1) hour
- Patients that are unable to undergo MRI evaluation for reasons specific to MRI
Exclusion
Key Trial Info
Start Date :
July 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04340180
Start Date
July 14 2021
End Date
December 30 2025
Last Update
October 3 2025
Active Locations (1)
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1
The Kirklin Clinic
Birmingham, Alabama, United States, 35249