Gadofosveset for Axillary Staging in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01437865
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : April 6, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Gadofosveset contrast agent enhanced MRI Axilla Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study
Study Start Date : September 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 Name: Gadofosveset (Ablavar/Vasovist) EMEA/H/C/000601

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01437865

Maastricht University Medical Center (MUMC) AZM
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Principal Investigator: R. Beets - Tan, MD, PhD Maastricht University Medical Center

Responsible Party: Maastricht University Medical Center Identifier: NCT01437865     History of Changes
Other Study ID Numbers: 11-2-016
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Maastricht University Medical Center:
lymph node metastases
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases