Gadofosveset for Axillary Staging in Breast Cancer Patients

Not Applicable

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: Gadofosveset contrast agent enhanced MRI Axilla

• Registration Number: NCT01437865
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-12
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gadofosveset enhanced MRI Axilla	Gadofosveset contrast agent enhanced MRI Axilla	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Maastricht University Medical Center (MUMC) AZM; 🇳🇱 Maastricht, Netherlands