Nodal Staging in Breast Cancer With MRL

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01609920
First received: May 30, 2012
Last updated: May 13, 2013
Last verified: May 2013

May 30, 2012
May 13, 2013
May 2012
December 2013   (final data collection date for primary outcome measure)
The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL 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 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.
The diagnostic performance (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 diagnostic performace (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 diagnostic performace can be calculated.
Complete list of historical versions of study NCT01609920 on ClinicalTrials.gov Archive Site
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Nodal Staging in Breast Cancer With MRL
Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset

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.

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Neoplasms
Drug: Gadofosveset enhanced MRL of axillary lymph nodes
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.
Other Names:
  • Vasovist
  • Ablavar
  • Gadofosveset
Experimental: Gadofosveset MRL
Intervention: Drug: Gadofosveset enhanced MRL of axillary lymph nodes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
March 2014
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Robert-Jan Schipper, MD 003143381575 robertjan.schipper@mumc.nl
Netherlands
 
NCT01609920
12-2-032
No
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: R.G.H. Beets-Tan, MD, PhD Maastricht University Medical Center
Maastricht University Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP