breast cancer
Conditions
Interventions
If a patient provides informed consent, she will undergo a PET/MRI with
dedicated axillary coil before surgical staging. As contrast agent the
radioactive tracer 18F-FDG will be used (no gadolinium-
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Female patient with histologically confirmed breast cancer and clinically confirmed negative lymph nodes in the axilla, scheduled to undergo SLNB 2. Patients who are willing and able to undergo the study procedures 3. The patient has provided personally written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients treated with neoadjuvant systemic therapy prior to axillary nodal staging 2. Patients with clinically positive axillary lymph nodes 3. Age 100 kg (because of the format of the PET/MRI scanner) 7. General contraindications for MRI (such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia) or PET (i.e. known allergy to 18F-FDG) 8. Hyperglycaemia (> 11 mmol/L) at the time of 18F-FDG injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The accuracy (sensitivity, specificity, PPV, NPV, FNR) of dedicated axillary hybrid PET/MRI versus pathological outcome of SLNB will be investigated. The accuracy of PET/MRI will be determined on the basis of node-by-node matching of the imaged nodes to the pathological outcome of SLNB and patient-by-patient analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the diagnostic value of the three MRI sequences (T2w, DWI and hybrid PET/MRI) using a dedicated axillary unenhanced hybrid PET/MRI protocol. | — |
Countries
Netherlands
Outcome results
None listed