OncRef

Clinical Trial: NCT04340180

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

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:University of Alabama at Birmingham
Information Provided By:University of Alabama at Birmingham
Last Update Posted:2026-07-01

Study Overview

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 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.

Official Title

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

Conditions

Breast Benign Tumor, Breast Malignant Tumor

Intervention / Treatment

  • Drug: Standard of Care (SOC) gadolinium Breast MRI
  • Drug: reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.

Other Study ID Numbers

  • IRB-300004720 R19-159
  • Bracco

Start Date (Actual)

2021-07-14

Primary Completion Date (Actual)

2022-09-29

Study Completion Date (Actual)

2026-01-20

Enrollment (Actual)

20

Study Type

Interventional

Phase

Phase 1