MedTrace Logo

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

NCT04340180 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

  • Breast Benign Tumor
  • Breast Malignant Tumor

Interventions

DRUG

Standard of Care (SOC) gadolinium Breast MRI

Standard of Care (SOC) gadolinium Breast MRI

DRUG

reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.

reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.

Sponsors & Collaborators

  • Bracco Corporate

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Stefanie Woodard, MD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2022-09-29
Completion
2026-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04340180 on ClinicalTrials.gov