Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction

Completed · Phase 1

Conditions studied: Breast Benign Tumor, Breast Malignant Tumor

In brief

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 relevant for several reasons, most notably being the reduction of MRI dose and decreased gadolinium deposition in the brain. In addition, use of AI may provide increased sensitivity and specificity for the radiologist evaluating a breast MRI exam. Half of the population will have benign pathologies and the other half will have malignant pathologies.

Key facts

Study ID

NCT04340180

Run by

University of Alabama at Birmingham

People needed

20

Starts

2021-07-14

Expected to finish

2026-01-20

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• The Kirklin Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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