Could cheaper scans replace MRI for women with dense breasts?
NCT ID NCT06636370
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
Women with extremely dense breasts have a higher risk of breast cancer, and tumors are harder to see on standard mammograms. This large study of 36,000 women aged 50-75 will test two extra screening methods—contrast-enhanced mammography and a shorter MRI—to see if they can find cancers earlier without overloading the healthcare system. Participants will get one of these scans after a normal mammogram, and researchers will track how many cancers are found between screenings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Contrast-enhanced mammography (CEM) and abbreviated MRI (AB-MRI)
- What this could lead to
- If successful, this could provide a more affordable and practical way to screen women with dense breasts for cancer, catching tumors earlier and reducing deaths.
- What could go wrong
- The trial is still recruiting and results are not yet available. The new methods may not be as effective as full MRI, or may cause more false alarms or side effects from contrast dye.
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 36,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Sep 2031
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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49 to 72 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Participant in the Dutch population-based breast cancer screening program with a negative mammography result (BI-RADS classification 1 or 2). * Extremely dense breast tissue (assessed with Quantra software, category D). * Age between 49-72 years (women are invited to the Dutch screening program in the year they turn 50, so the minimum age is 49 years. The maximum age for inclusion is 72 years to ensure that women can still participate in a second round of supplemental screening). * Living in the service area (travel distance of up to 60 km) of the 15 participating hospitals. * Absence of breast implants (Quantra cannot provide an accurate density determination for breasts with implants). * No objection to data sharing. * Not a participant in the DENSE trial or STREAM trial (participants in the DENSE and STREAM trials are known to the Dutch screening organization). Exclusion Criteria: The additional exclusion criteria for the intervention arms are checked after randomization and recruitment (this order is due to the pre-randomization design): * Presence of in-body metals (only for AB-MRI, this involves specific metals and is asked by telephone). * Previous allergic reaction to the provided contrast agent. * Renal insufficiency (glomerular filtration rate \<30 ml/min) (only for CEM, is checked for with questionnaire I and possibly renal function measurement). * Severe claustrophobia (only for AB-MRI). * Severe obesity (weight \>150 kg) (only for AB-MRI).
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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UMC Utrecht
RECRUITINGUtrecht, Netherlands
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