Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction
Primary Purpose
Breast Benign Tumor, Breast Malignant Tumor
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Standard of Care (SOC) gadolinium Breast MRI
reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.
Sponsored by

About this trial
This is an interventional diagnostic trial for Breast Benign Tumor
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
Sites / Locations
- The Kirklin Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with enhancing breast lesions
Arm Description
Outcomes
Primary Outcome Measures
Compare lesion conspicuity on a scale of 1-4 from low-dose and SOC-dose imaging.
Compare lesion size in millimeters from low-dose to SOC-dose imaging.
Compare lesion margins on a scale from 1-4 from low-dose and SOC-dose imaging.
Compare lesion internal enhancement pattern on a scale from 1-4 from low-dose and SOC- dose imaging.
Secondary Outcome Measures
Compare the overall background enhancement (scale per standard imaging guidelines. Minimal, mild, moderate, marked).
Full Information
NCT ID
NCT04340180
First Posted
March 31, 2020
Last Updated
October 20, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Bracco Corporate
1. Study Identification
Unique Protocol Identification Number
NCT04340180
Brief Title
Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction
Official Title
Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Bracco Corporate
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Benign Tumor, Breast Malignant Tumor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with enhancing breast lesions
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Standard of Care (SOC) gadolinium Breast MRI
Intervention Description
Standard of Care (SOC) gadolinium Breast MRI
Intervention Type
Drug
Intervention Name(s)
reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.
Intervention Description
reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.
Primary Outcome Measure Information:
Title
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).
Title
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).
Title
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).
Title
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).
Secondary Outcome Measure Information:
Title
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).
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefanie Woodard, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
To be determined.
Learn more about this trial
Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction
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