Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction (NCT04340180) | Clinical Trial Compass
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 range
18 Years – 99 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).
2
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).
3
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).
4
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).