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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 1

Conditions: Breast Malignant Tumor; Breast Benign Tumor

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04340180

R19-159

000527412 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Subjects with enhancing breast lesions

Experimental group

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.