Gadofosveset for Axillary Staging in Breast Cancer Patients

Overview

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.

Full Title of Study: “Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study”

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: February 2012

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Gadofosveset enhanced MRI Axilla

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging.

2. Tumor must be a T2 according the TNM 6-classification.

3. The ultrasound of the axilla must be suspect for nodal metastases.

4. Willing and able to undergo all study procedures

5. Has personally provided written informed consent.

Exclusion Criteria

1. Age <18

2. History of prior chemotherapy

3. History of prior radiotherapy of the surrounding areas of the axilla.

4. Pregnancy

5. Contra indications for MRI such as pacemaker, aneurysm clips or severe claustrophobia.

6. Allergy to any of the ingredients of Gadofosveset (VasovistĀ® /AblavarĀ®)

7. Being unable to give informed consent in person

8. Acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2).

9. Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

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. Beets – Tan, MD, PhD, Principal Investigator, Maastricht University Medical Center

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