Actively Recruiting
fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases
Led by European Institute of Oncology · Updated on 2026-01-06
145
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the usefulness of Diffusion Whole Body Magnetic Resonance Imaging (DWB-MRI) for early detection of locoregional or distant recurrence in patients with high-risk breast cancer subtypes, specifically HER2-positive or Triple Negative breast cancer. The study aims to see if early diagnosis through this imaging method improves 5-year overall survival compared to current follow-up methods. Breast cancer is a common cancer among women, with distant metastases being the main cause of death, and this trial explores more tailored follow-up based on cancer biology and subtype. Participants will undergo surveillance using DWB-MRI, which involves a detailed MRI protocol including sagittal T1-weighted and T2-weighted sequences of the spine and axial images from head to mid-thigh on a 1.5 Tesla scanner. This imaging technique is being studied to detect metastases early and monitor therapy. The study includes patients who have undergone surgery or neoadjuvant treatment and have no distant metastases at baseline imaging. This approach may help identify patients with low disease burden who might benefit from curative treatments. During the study, participants will be monitored over a period of up to five years. Researchers will assess 5-year overall survival as the primary outcome. Secondary outcomes include survival after local treatment, breast cancer-specific survival, safety of local treatments, assessments of anxiety, health state, coping ability, personality, and patient acceptance of DWB-MRI over 48 months. Participants will be regularly evaluated through imaging and questionnaires, with follow-up care coordinated to study the impact of early detection on prognosis and quality of life.
CONDITIONS
Brief Title
fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Histologically confirmed invasive breast cancer stage II or III HER2-positive or Triple Negative subtype
- Patients who have undergone surgery or neoadjuvant treatment with residual disease at surgery
- No evidence of distant metastases on baseline radiological staging within 1 month from surgery
- No significant comorbidities
- ECOG performance status 0
- Geographically able to attend follow-up
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Absolute contraindications to MRI preventing its execution
- Relative contraindications to MRI where safety is not fully assured
- Age over 75 years
- Previous or concurrent other malignancies except basal or squamous cell skin cancer or treated in situ cervical carcinoma
- Uncontrolled illnesses such as symptomatic congestive heart failure, unstable angina, psychiatric illness, or social conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants undergo surveillance with diffusion whole body MRI to monitor for early detection of breast cancer metastases.
Regular MRI scans during follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
European Institute of Oncology
Milan, Italy, 20141
Actively Recruiting
Research Team
M
Monica Iorfida, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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