on-invasive nodal staging in breast cancer with MRI Lymphography using gadofosveset.

Phase 3

Completed

Conditions: Breast cancer
Lymph node metastases
10006291

Registration Number: NL-OMON43763

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 97

Inclusion Criteria

1. Female patient with histopathologically confirmed breast cancer about to undergo nodal staging.
2. Willing and able to undergo all study procedures
3. Has personally provided written informed consent;Additional inclusion criteria for 2nd axilla-MRI
1. Patient treated with neo-adjuvant therapy
2. Indication for ALND after neo-adjuvant therapy as result of regular treatment

Exclusion Criteria

1. Age <18
2. Pregnancy
3. Contra indications for MRI such as pacemaker, aneurysm clips or severe claustrophobia.
4. Allergy to any of the ingredients of Gadofosveset (Ablavar®)
5. Being unable to give informed consent in person
6. Acute or chronic severe renal insufficiency (glomerular filtration rate < 45mL/min/1.73m2)
7. Acute renal insufficiency of any severity due to the hepato-renal syndrome
8. Known (or suspicion of) QT- prolongation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter will be the accuracy (sensitivity, specificity, NPV<br /><br>and PPV) of the MRL in predicting the<br /><br>involvement of metastases in the investigated lymph nodes. We will compare the<br /><br>results of the MRL with the pathological<br /><br>results of a negative SLNB or the ALND.<br /><br>In cases with a positive MRL and negative SLNB, we will investigate if the MRL<br /><br>is really wrong, or that we probably found<br /><br>a case of a false negative SNLB procedure.</p><br>

Secondary Outcome Measures