Nodal Staging in Breast Cancer With MRL

This study is currently recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 30, 2012

Last Updated Date

May 13, 2013

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT01609920 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nodal Staging in Breast Cancer With MRL

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Breast Neoplasms

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Gadofosveset MRL

Intervention: Drug: Gadofosveset enhanced MRL of axillary lymph nodes

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

March 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Robert-Jan Schipper, MD

003143381575

robertjan.schipper@mumc.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01609920

Other Study ID Numbers ^ICMJE

12-2-032

Has Data Monitoring Committee

Responsible Party

Maastricht University Medical Center

Study Sponsor ^ICMJE

Maastricht University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

R.G.H. Beets-Tan, MD, PhD

Maastricht University Medical Center

Information Provided By

Maastricht University Medical Center

Verification Date

May 2013

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

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