Gadofosveset for Axillary Staging in Breast Cancer Patients
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study|
- The accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases [ Time Frame: Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks. ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
|Experimental: Gadofosveset enhanced MRI Axilla||
Drug: Gadofosveset contrast agent enhanced MRI Axilla
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.
Other Name: Gadofosveset (Ablavar/Vasovist) EMEA/H/C/000601
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437865
|Maastricht University Medical Center (MUMC) AZM|
|Principal Investigator:||R. Beets - Tan, MD, PhD||Maastricht University Medical Center|