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

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.

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.

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.


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with enhancing breast lesions<br> | Drug: Standard of Care (SOC) gadolinium Breast MRI<br>* Standard of Care (SOC) gadolinium Breast MRI<br>Drug: reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.<br>* reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare lesion conspicuity on a scale of 1-4 from low-dose and SOC-dose imaging. |  | From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later). | 
| Compare lesion size in millimeters from low-dose to SOC-dose imaging. |  | From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later). | 
| Compare lesion margins on a scale from 1-4 from low-dose and SOC-dose imaging. |  | From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later). | 
| Compare lesion internal enhancement pattern on a scale from 1-4 from low-dose and SOC- dose imaging. |  | From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the overall background enhancement (scale per standard imaging guidelines. Minimal, mild, moderate, marked). |  | From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later). |