Gadofosveset for Axillary Staging in Breast Cancer Patients

Condition(s) targeted: Breast Neoplasms

Intervention: Gadofosveset contrast agent enhanced MRI Axilla (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Maastricht University Medical Center

Official(s) and/or principal investigator(s):
R. Beets - Tan, MD, PhD, Principal Investigator, Affiliation: Maastricht University Medical Center

Overall contact:
Robert-Jan Schipper, MD, Phone: 0031433877477, Email: robertjan.schipper@mumc.nl

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.

Official title: Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study

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

Primary outcome: The accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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 (Vasovist® /Ablavar®)

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.

Robert-Jan Schipper, MD, Phone: 0031433877477, Email: robertjan.schipper@mumc.nl

Maastricht University Medical Center (MUMC) AZM, Maastricht, Netherlands; Recruiting
Robert-Jan Schipper, MD, Phone: 0031433877477, Email: robertjan.schipper@mumc.nl

Starting date: September 2011
Last updated: September 20, 2011