Nodal Staging in Breast Cancer With MRL

Study Overview
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Brief Summary
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The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL). The diagnostic performance 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 sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the golden standard for nodal involvement.

Official Title
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Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Gadofosveset enhanced MRL of axillary lymph nodes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patient with histopathologically confirmed breast cancer about to undergo nodal staging. Willing and able to undergo all study procedures Has personally provided written informed consent. Exclusion Criteria: Age <18, Pregnancy Contra indications for MRL 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 <45 mL/min/1.73m2)1. Acute renal insufficiency of any severity due to the hepato-renal syndrome. Known (or suspicion of) QT- prolongation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gadofosveset MRL<br> | Drug: Gadofosveset enhanced MRL of axillary lymph nodes<br>* A MRL 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;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases | The main study parameter will be the diagnostic performace (sensitivity, specificity, NPV and PPV) of the axillary MRL in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRL 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 diagnostic performace 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
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Keywords Provided by Centre Hospitalier Valida
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MRI, lymph node metastases, breast cancer, gadofosveset