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Gadofosveset for Axillary Staging in Breast Cancer Patients

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Gadofosveset contrast agent enhanced MRI Axilla
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasms focused on measuring MRI, lymph node metastases, breast cancer, gadofosveset

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Maastricht University Medical Center (MUMC) AZM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gadofosveset enhanced MRI Axilla

Arm Description

Outcomes

Primary Outcome Measures

The accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases
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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2011
Last Updated
April 5, 2012
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01437865
Brief Title
Gadofosveset for Axillary Staging in Breast Cancer Patients
Official Title
Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
MRI, lymph node metastases, breast cancer, gadofosveset

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gadofosveset enhanced MRI Axilla
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gadofosveset contrast agent enhanced MRI Axilla
Other Intervention Name(s)
Gadofosveset (Ablavar/Vasovist) EMEA/H/C/000601
Intervention Description
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.
Primary Outcome Measure Information:
Title
The accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases
Description
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.
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Beets - Tan, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center (MUMC) AZM
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

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Gadofosveset for Axillary Staging in Breast Cancer Patients

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