NCT04340180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 14, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2022

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

March 31, 2020

Last Update Submit

January 20, 2026

Conditions

Breast Malignant TumorBreast Benign Tumor

Outcome Measures

Primary Outcomes (4)

  • 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).

  • 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).

  • 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).

  • 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 Outcomes (1)

  • 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).

Study Arms (1)

Subjects with enhancing breast lesions

EXPERIMENTAL
Drug: Standard of Care (SOC) gadolinium Breast MRIDrug: reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.

Interventions

reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.DRUG

reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.

Subjects with enhancing breast lesions
Standard of Care (SOC) gadolinium Breast MRIDRUG

Standard of Care (SOC) gadolinium Breast MRI

Subjects with enhancing breast lesions

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Kirklin Clinic

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Standard of CareArtificial Intelligence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationAlgorithmsMathematical Concepts

Study Officials

  • Stefanie Woodard, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Program Director, Diagnostic Radiology Residency Program Assistant Professor, Breast Imaging Section

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 9, 2020

Study Start

July 14, 2021

Primary Completion

September 29, 2022

Study Completion

January 20, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

To be determined.

Locations

US(1)