on-invasive axillary lymph node staging in breast cancer with PET/MRI

Recruiting

Conditions: breast cancer
10006291

Registration Number: NL-OMON54725

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 125

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

1. Patients treated with neoadjuvant systemic therapy prior to axillary nodal
staging
2. Patients with clinically positive axillary lymph nodes
3. Age < 18 years
4. Inability to provide informed consent
5. Pregnancy
6. Weight >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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The accuracy (sensitivity, specificity, PPV, NPV, FNR) of dedicated axillary<br /><br>hybrid PET/MRI versus pathological outcome of SLNB will be investigated. The<br /><br>accuracy of PET/MRI will be determined on the basis of node-by-node matching of<br /><br>the imaged nodes to the pathological outcome of SLNB and patient-by-patient<br /><br>analysis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate the diagnostic value of the three MRI sequences (T2w, DWI and<br /><br>hybrid PET/MRI) using a dedicated axillary unenhanced hybrid PET/MRI protocol.</p><br>