Whole-Body MRI could spot hidden breast cancer spread sooner
NCT ID NCT06328465
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a special whole-body MRI scan can find breast cancer that has come back or spread to other parts of the body earlier than standard methods. Researchers will follow 145 women with aggressive breast cancer types (HER2+ or triple-negative) for five years to see if early detection improves survival. The goal is to see if this scan helps doctors treat recurrences more effectively.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Diffusion whole body MRI (diagnostic test)
- What this could lead to
- If successful, this could show that regular whole-body MRI scans help catch breast cancer recurrences earlier, potentially leading to better treatment and longer survival for high-risk patients.
- What could go wrong
- This is a relatively small, early-stage study (145 people) without a comparison group, so results may not be conclusive. The MRI might find false alarms or not improve survival as hoped.
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
-
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
-
About 145 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2019
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Pre or post-menopausal patient with histologically confirmed invasive breast cancer stage II - III HER2 + or TN operated breast carcinoma or patients underwent neoadjuvant treatment (included cT4d) with residual disease at definitive surgery * No evidence of distant metastases at baseline perioperative radiological staging (DWB-MRI, total body Computed Tomography (CT) or Positron Emission Tomography (PET/CT) must be performed +/- 1 month from surgery) * No relevant comorbidities * Eastern Cooperative Oncology Group (ECOG) performance status 0 * Geographically accessible for follow up * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Absolute contraindications that exclude the execution of the MRI investigation, regardless of the clinical indication * Relative contraindications that include situations in which the innocuousness of the examination is not documented with certainty that therefore do not recommend the execution, except for serious indications related to the patient's clinical need * Older age (\>75 years) * Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix * Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HER2-positive breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
European Institute of Oncology
RECRUITINGMilan, 20141, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cholesterol drug simvastatin joins chemo in breast cancer trial
- Two-Drug HER2 attack vs one: which First-Line strategy helps advanced breast cancer patients live longer?
- Gut bacteria may hold clues to why some cancer treatments work better
- Microscope aims to spare breast cancer patients a second surgery
- Unlocking TNBC survival: genetic clues from 3,648 women
- New drug targets Sugar-Coated proteins on cancer cells