Using MRI to detect early breast cancer metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of Diffusion Whole Body-Magnetic Resonance Imaging (DWB-MRI) in the early detection of locoregional or distant recurrence of breast cancer in high-risk patients. It focuses on individuals with HER2-positive or high-risk Triple Negative breast cancer, assessing whether early diagnosis can improve overall survival rates. The study will monitor patients over five years to determine the impact of DWB-MRI on treatment outcomes compared to traditional follow-up methods.

Why it matters

Who can join: the full rules

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

Where it's running

• European Institute of Oncology
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Monica Iorfida, MD — European Institute of Oncology
• Study coordinator: Monica Iorfida, MD
• Email: monica.iorfida@ieo.it
• Phone: +390257489970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.