Gadofosveset for Axillary Staging in Breast Cancer Patients

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center (MUMC) AZM

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gadofosveset contrast agent enhanced MRI Axilla

Drug

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.

Other names: Gadofosveset (Ablavar/Vasovist) EMEA/H/C/000601

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Sep 21, 2011
Registry last updated: Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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