Contrast-Free Magnetic Resonance Imaging for Breast Disease (NCT05006196) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Contrast-Free Magnetic Resonance Imaging for Breast Disease
United Kingdom1,030 participantsStarted 2021-07-06
Plain-language summary
Prospective, observational cohort study looking at patients either at risk of breast cancer or have clinically suspected breast to assess the diagnostic performance of quantitative, non-contrast MRI.
Who can participate
Age range
30 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:
* Female 30 years of age and over
* Participant has been referred to a secondary care breast screening clinic.
* Participant is willing and able to give informed consent for participation in the investigation.
Exclusion Criteria
* The participant may not enter the study with any known contraindication to magnetic resonance imaging (including but not limited to a pacemaker or other metallic unfixed implanted device, metallic fragments, extensive tattoos, severe claustrophobia).
* Any other cause, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.
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.
1This trial is testing a type of breast MRI that doesn't require contrast dye — could that be relevant for me if I have concerns about contrast agents or kidney problems that make standard MRI with dye risky?
2Since this study is 'active, not recruiting,' is there any way for me to access or benefit from a non-contrast MRI approach, or is this something I'd need to wait for until the results are published and adopted into practice?
3How does the diagnostic accuracy of a contrast-free MRI compare to the standard contrast-enhanced MRI my care team currently uses — and is there any risk that a non-contrast approach might miss something important in my specific situation?
4This trial is listed as 'Phase NA,' which often means it's an imaging or diagnostic study rather than a treatment trial — does that mean the main goal is just to test how well this scan works, and would participating or using this technology change any treatment decisions for me?
5Are there other studies or existing options for contrast-free breast imaging that my care team already has access to, or is this still considered experimental at this point?
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
Determine the diagnostic performance of a non-contrast MRI in breast disease