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

Breast Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04340180
• Other study ID #: R19-159
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 14, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Benign Tumor
• Breast Malignant Tumor
• Breast Neoplasms

Intervention

Drug:
• Standard of Care (SOC) gadolinium Breast MRI
Standard of Care (SOC) gadolinium Breast MRI
• 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.

Locations

Country	Name	City	State
United States	The Kirklin Clinic	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Bracco Corporate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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	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).