PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Axillary lymph node status is an important prognostic factor for patients with breast cancer. After breast cancer diagnosis, current nodal staging consists of axillary ultrasound (US) combined with tissue sampling when deemed necessary. In case of positive axillary lymph nodes, patients will undergo axillary lymph node dissection (ALND). In case of no suspicious axillary lymph nodes (i.e. clinically node negative patients), patients will undergo sentinel lymph node biopsy (SLNB). This surgical nodal staging is accompanied by co-morbidity. In theory, if non-invasive imaging can evaluate the lymph node status accurately, a node negative patient would no longer have to undergo axillary surgery. Since MRI is suitable for soft tissue imaging and PET has the advantage of showing increased metabolic uptake in lymph node metastases, a combination of these techniques in hybrid PET/MRI would be highly desirable. If dedicated axillary hybrid PET/MRI is equally accurate to SLNB for the detection of negative axillary lymph nodes, work-up could be more efficient by bypassing SLNB. However, the accuracy of dedicated axillary hybrid PET/MRI needs to be compared with the pathological outcome of SLNB (gold standard) first.

Official Title
-----------------
Non-invasive Axillary Lymph Node Staging in Breast Cancer With PET-MRI

Conditions
-----------------
Breast Cancer, Breast Neoplasms, Breast Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Dedicated axillary hybrid PET-MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patient with histologically confirmed breast cancer and clinically confirmed negative lymph nodes in the axilla, scheduled to undergo SLNB Patients who are willing and able to undergo the study procedures The patient has provided personally written informed consent Exclusion Criteria: Patients treated with neoadjuvant systemic therapy prior to axillary nodal staging Patients with clinically positive axillary lymph nodes Age < 18 years Inability to provide informed consent Pregnancy Weight >100 kg (because of the format of the PET/MRI scanner) 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) Hyperglycaemia (> 11 mmol/L) at the time of 18F-FDG injection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dedicated axillary hybrid PET-MRI axilla<br> | Diagnostic Test: Dedicated axillary hybrid PET-MRI<br>* All clinically node negative patients will undergo a hybrid PET-MRI axilla preoperatively, followed by breast surgery and SLNB.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of dedicated hybrid PET/MRI | Accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of dedicated axillary hybrid PET/MRI to exclude axillary lymph node metastases will be calculated. | Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of T2w MRI, DWI and Hybrid PET/MRI | Accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of three MRI sequences (T2w, DWI and hybrid PET/MRI) to exclude axillary lymph node metastases will be calculated separately as well. | Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks |