Gadofosveset for Axillary Staging in Breast Cancer Patients

Maastricht University Medical Center10 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Neoplasms

Interventions

Gadofosveset contrast agent enhanced MRI AxillaDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Maastricht University Medical Center (MUMC) AZM

Maastricht, Netherlands

Outcomes

Primary Outcomes

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

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.

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.

Data from ClinicalTrials.gov

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