Gadofosveset for Axillary Staging in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared to current nodal staging methods. The accuracy of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the SNLB or ALND will be regarded as the golden standard for nodal involvement.

Official Title
-----------------
Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: Gadofosveset contrast agent enhanced MRI Axilla


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging. Tumor must be a T2 according the TNM 6-classification. The ultrasound of the axilla must be suspect for nodal metastases. Willing and able to undergo all study procedures Has personally provided written informed consent. Exclusion Criteria: Age <18 History of prior chemotherapy History of prior radiotherapy of the surrounding areas of the axilla. Pregnancy Contra indications for MRI such as pacemaker, aneurysm clips or severe claustrophobia. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®) Being unable to give informed consent in person Acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2). Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

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: Gadofosveset enhanced MRI Axilla<br> | Drug: Gadofosveset contrast agent enhanced MRI Axilla<br>* A MRI of the Axilla will be performed before and after administration of a single IV bolus injection of gadofosveset of an equivalent of 0.03 mmol Gd/kg body weight at an injection speed of 1.5 mL/sec., followed by a saline flush of 25 mL at an injection speed of 1.5 mL/sec.<br>* Other names: Gadofosveset (Ablavar/Vasovist) EMEA/H/C/000601;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases | The main study parameter will be the accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRI as 0= benign, 1=malign. These results will be compared with the histopathological results of the SNLB procedure of ALND procedure on an node by node basis. So the accuray can be calculated. | Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, lymph node metastases, breast cancer, gadofosveset