Back to results

Nodal Staging in Breast Cancer With MRL

Primary Purpose

Breast Neoplasms

Status

Terminated

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Gadofosveset enhanced MRL of axillary lymph nodes

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:

Female patient with histopathologically confirmed breast cancer about to undergo nodal staging.
Willing and able to undergo all study procedures
Has personally provided written informed consent.

Exclusion Criteria:

Age <18,
Pregnancy
Contra indications for MRL 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 <45 mL/min/1.73m2)1.
Acute renal insufficiency of any severity due to the hepato-renal syndrome.
Known (or suspicion of) QT- prolongation

Sites / Locations

Maastricht University Medical Center (MUMC) AZM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gadofosveset MRL

Arm Description

Outcomes

Primary Outcome Measures

The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases

The main study parameter will be the diagnostic performace (sensitivity, specificity, NPV and PPV) of the axillary MRL in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRL 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 diagnostic performace can be calculated.

Secondary Outcome Measures

Full Information

NCT ID

NCT01609920

First Posted

May 30, 2012

Last Updated

November 9, 2016

Sponsor

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01609920

Brief Title

Nodal Staging in Breast Cancer With MRL

Official Title

Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Terminated

Why Stopped

Manufacturer recently halted production of gadofosveset.

Study Start Date

May 2012 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL). The diagnostic performance 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 sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (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

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gadofosveset MRL

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Gadofosveset enhanced MRL of axillary lymph nodes

Other Intervention Name(s)

Vasovist, Ablavar, Gadofosveset

Intervention Description

A MRL 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 diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases

Description

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

Eligibility Criteria

Inclusion Criteria: Female patient with histopathologically confirmed breast cancer about to undergo nodal staging. Willing and able to undergo all study procedures Has personally provided written informed consent. Exclusion Criteria: Age <18, Pregnancy Contra indications for MRL 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 <45 mL/min/1.73m2)1. Acute renal insufficiency of any severity due to the hepato-renal syndrome. Known (or suspicion of) QT- prolongation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

R.G.H. 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

State/Province

Limburg

ZIP/Postal Code

6225 HX

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

Nodal Staging in Breast Cancer With MRL

We'll reach out to this number within 24 hrs