Nodal Staging in Breast Cancer With MRL

Overview

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.

Full Title of Study: “Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Gadofosveset MRL

Clinical Trial Outcome Measures

Primary 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.
    • 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.

Participating in This Clinical Trial

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 (VasovistĀ® /AblavarĀ®)

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maastricht University Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • R.G.H. Beets-Tan, MD, PhD, Principal Investigator, Maastricht University Medical Center

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