Artificial Intelligence Algorithm and Low Dose Gadolinium MRI for the Detection of Breast Cancer

This phase I study is to find out the ability of artificial intelligence (AI) algorithm in combination with low dose gadolinium magnetic resonance imaging (MRI) in detecting breast cancer. An AI algorithm is a computer software program that is created to do certain commands. The AI algorithm may reduce the dose of gadolinium contrast during breast MRI scans, improve images, and decrease gadolinium deposition in the brain.

Inclusion Criteria

Patients included in this study will be aged 18-99 presenting with current breast cancer with the following stipulations: * Those who have not yet started chemotherapy are included * Patients must be new breast cancer diagnoses * The cancer must be primary breast (not metastatic disease to the breast)
For patients presenting with non-malignant indications (screening or BIRADS 3), they must have a prior exam with known enhancing mass, nonmass enhancement, or focus/foci

Exclusion Criteria

Pregnant and lactating patients, minors, prisoners, and men
Patients who have already received a dose of neoadjuvant chemotherapy are excluded
Patients with recurrent breast cancer are also excluded as there may be technical limitations in lumpectomy bed imaging or mastectomy cases
Anyone unable to undergo MRI evaluation for reasons specific to MRI

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04340180.

PRIMARY OBJECTIVE:

I. 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.

OUTLINE:

Patients receive standard of care gadolinium intravenously (IV) and undergo MRI. Between 2 to 14 days after standard of care MRI, patients receive low-dose gadolinium IV and undergo MRI over 30 minutes with AI.

Trial PhasePhase I

Trial Typediagnostic

Lead OrganizationUniversity of Alabama at Birmingham Cancer Center

Principal InvestigatorStefanie A Woodard

Primary IDUAB2017
Secondary IDsNCI-2021-10719
ClinicalTrials.gov IDNCT04340180

Artificial Intelligence Algorithm and Low Dose Gadolinium MRI for the Detection of Breast Cancer

Inclusion Criteria

Exclusion Criteria

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Artificial Intelligence Algorithm and Low Dose Gadolinium MRI for the Detection of Breast Cancer

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