CompletedPhase 1

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

United States20 participantsStarted 2021-07-14

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Compare lesion conspicuity on a scale of 1-4 from low-dose and SOC-dose imaging.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).

Trial details

NCT IDNCT04340180

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-29

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