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

March 26, 2024 updated by: Stefanie A. Woodard, University of Alabama at Birmingham
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • The Kirklin Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects with enhancing breast lesions
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare lesion conspicuity on a scale of 1-4 from low-dose and SOC-dose imaging.
Time Frame: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
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.
Time Frame: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
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.
Time Frame: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
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.
Time Frame: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Bracco Corporate

Investigators

  • Principal Investigator: Stefanie Woodard, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2021

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R19-159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To be determined.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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