NCT04340180

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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 regarding dosing) gadolinium MRI exam. Both exams will be performed on a 1.5 Tesla magnet. Both exams will include a full protocol. The full dose contrast exam will be read as standard protocol. All images will be anonymized. Images from the reduced dose study will be collected and an AI algorithm applied. All three anonymized data sets (regular dose, low dose, and AI algorithm applied to low dose) will be provided to the readers. Readers will be three attending radiologists specializing in breast imaging. Exams will be scored on quality, background parenchymal enhancement (BPE), and lesion conspicuity. Enhancing lesions will be identified and characterized by the radiologists in a document provided.

Conditions

• Breast Benign Tumor
• Breast Malignant Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-14
• Primary completion: 2022-09-29
• Completion: 2026-01-20
• First posted: 2020-04-09
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study