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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
  Purpose

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.


Condition Intervention
Breast Neoplasms
 Drug: Gadofosveset enhanced MRL of axillary lymph nodes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 160
Study Start Date: May 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gadofosveset MRL 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609920

Contacts
Contact: Robert-Jan Schipper, MD 003143381575 robertjan.schipper@mumc.nl

Locations
Netherlands
Maastricht University Medical Center (MUMC) AZM Recruiting
Maastricht, Limburg, Netherlands, 6225 HX
Contact: Robert-Jan Schipper, MD     003143381575     robertjan.schipper@mumc.nl    
Principal Investigator: R.G.H. Beets-Tan, MD, PhD            
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: R.G.H. Beets-Tan, MD, PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01609920     History of Changes
Other Study ID Numbers: 12-2-032
Study First Received: May 30, 2012
Last Updated: May 13, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
MRI
lymph node metastases
breast cancer
gadofosveset

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013