AI-Powered MRI could revolutionize breast cancer screening without contrast dyes
NCT ID NCT07205276
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will test whether artificial intelligence can analyze non-contrast breast MRI scans to detect cancer early, avoiding the need for contrast agents that can be costly and risky. Researchers plan to enroll 30,000 women aged 30-70 and compare AI readings to standard radiologist interpretations. If successful, this approach could offer a safer, more accessible screening option, especially for women with dense breast tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Non-contrast multiparametric breast MRI with AI-based radiomics analysis
- What this could lead to
- If successful, this could provide a safer, more accurate breast cancer screening method that avoids contrast agents and works well for women with dense breast tissue.
- What could go wrong
- The AI model is still being developed and validated; it may not perform as well in real-world settings or across diverse populations. The trial is not yet recruiting, so results are years away.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* Inclusion Criteria: 1. Female, age 30-70 years 2. Completed breast MRI scan, including at least T2WI, DWI, and ADC sequences 3. Multimodal data acquired within the same time window (≤90 days) 4. A clear clinical outcome: pathologically confirmed or ≥12-24 months of negative follow-up 5. The time window between imaging examination and outcome determination was ≤90 days 6. Signed informed consent * Exclusion Criteria: 1. Absolute contraindications to MRI (pacemaker, cochlear implant, ocular metal foreign body, etc.) 2. Pregnant or lactating women 3. Recent history of breast surgery/radiotherapy (≤6 months) or imaging after neoadjuvant therapy 4. Substandard image quality (severe motion artifact, signal-to-noise ratio below threshold) 5. Incomplete clinical data or time window exceeded 6. Known breast cancer metastasis or recurrence
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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