New study tests cheaper breast cancer screening for High-Risk women
NCT ID NCT06629896
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares contrast-enhanced mammography (CEM) to the standard MRI plus digital mammography for screening women at high risk of breast cancer. About 2200 women aged 35-60 with a 5-year risk of 5% or higher will be randomly assigned to one of the two screening methods over two rounds. The goal is to see if CEM, which is faster and less expensive, can detect breast cancer just as well as MRI.
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 magnetic resonance imaging (MRI) with digital mammography
- What this could lead to
- If CEM works as well as MRI, it could offer a faster, cheaper, and more accessible screening option for women at high risk of breast cancer.
- What could go wrong
- This is a Phase 2 trial with 2200 participants, so results are preliminary. CEM may not detect cancers as accurately as MRI, and the study only follows women for 2.5 years.
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 2,200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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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35 to 60 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women at high risk of developing breast cancer already in care at participating centers or new referral for early diagnosis programs, aged between 35 and 60 years, with an estimated risk of breast cancer in the next 5 years \>=5%. To estimate the 5-year risk, centers may use one of the following models and criteria: * Tyrer Cuzick IBIS: criterion \>10% at 10 years; * BOADICEA: criterion \>10% at 10 years; * BCSC: criterion \>10% at 10 years (if possible switch to Tyrer-Cuzick if \>=2 relatives with breast or ovarian cancer); * MyPeBS (Mammorisk): woman included at very high risk in the MyPeBS study and who has completed the active follow-up period; * Women with previous chest irradiation for radiotherapy Exclusion Criteria: * \- Previous breast cancer; * Pregnancy; * Bilateral mastectomy; * Psychiatric or other disorders not compatible with compliance with the protocol and follow-up requirements; * Women who do not intend or cannot be followed for at least 2.5 years; * Women are unable to understand the information or to express a truly informed consent or non-consent to participation.
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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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Istituto in tecnologie avanzate e modelli assistenziali in oncologia - AUSL-IRCCS Reggio Emilia
RECRUITINGReggio Emilia, Italy/Reggio Emilia, 42122, Italy
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