Back to results

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.

About this trial

This is an interventional diagnostic trial for Breast Benign Tumor

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Product Manufactured in and Exported from the U.S.

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