Nodal Staging in Breast Cancer With MRL
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
MRI, lymph node metastases, breast cancer, gadofosveset
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Gadofosveset enhanced MRL of axillary lymph nodes
Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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.

Exclusion Criteria:

1. Age <18,

2. Pregnancy

3. Contra indications for MRL such as pacemaker, aneurysm clips or severe claustrophobia.

4. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)

5. Being unable to give informed consent in person

6. Acute or chronic severe renal insufficiency (glomerular filtration rate <45 mL/min/1.73m2)1.

7. Acute renal insufficiency of any severity due to the hepato-renal syndrome.

8. Known (or suspicion of) QT- prolongation
Location
Maastricht University Medical Center (MUMC) AZM
Maastricht, Limburg, Netherlands
Status: Recruiting
Contact: Robert-Jan Schipper, MD - 003143381575 - robertjan.schipper@mumc.nl
Start Date
May 2012
Completion Date
March 2014
Sponsors
Maastricht University Medical Center
Source
Maastricht University Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page