Gadofosveset for Axillary Staging in Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01437865
First received: September 12, 2011
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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 Intervention
Breast Neoplasms
Drug: Gadofosveset contrast agent enhanced MRI Axilla

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437865

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

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01437865     History of Changes
Other Study ID Numbers: 11-2-016
Study First Received: September 12, 2011
Last Updated: April 5, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Contrast Media
Gadofosveset trisodium
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014