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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-14

Study Completion Date

2026-01-20

Brief Summary

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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.

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Detailed Description

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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

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Breast Benign Tumor Breast Malignant Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subjects with enhancing breast lesions

Group Type EXPERIMENTAL

Standard of Care (SOC) gadolinium Breast MRI

Intervention Type DRUG

Standard of Care (SOC) gadolinium Breast MRI

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

Intervention Type DRUG

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

Interventions

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Standard of Care (SOC) gadolinium Breast MRI

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No