Gadofosveset for Axillary Staging in Breast Cancer Patients

April 5, 2012 updated by: Maastricht University Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center (MUMC) AZM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gadofosveset enhanced MRI Axilla
Drug: Gadofosveset contrast agent enhanced MRI Axilla
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: R. Beets - Tan, MD, PhD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

September 12, 2011

First Submitted That Met QC Criteria

September 20, 2011

First Posted (ESTIMATE)

September 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 6, 2012

Last Update Submitted That Met QC Criteria

April 5, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-2-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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