Gadofosveset for Axillary Staging in Breast Cancer Patients

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Breast Neoplasms

Treatments

Drug: Gadofosveset contrast agent enhanced MRI Axilla

Study type

Interventional

Funder types

Other

Identifiers

NCT01437865

11-2-016

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging.
Tumor must be a T2 according the TNM 6-classification.
The ultrasound of the axilla must be suspect for nodal metastases.
Willing and able to undergo all study procedures
Has personally provided written informed consent.

Exclusion criteria

Age <18
History of prior chemotherapy
History of prior radiotherapy of the surrounding areas of the axilla.
Pregnancy
Contra indications for MRI such as pacemaker, aneurysm clips or severe claustrophobia.
Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)
Being unable to give informed consent in person
Acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2).
Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.