Nodal Staging in Breast Cancer With MRL

Not Applicable

Terminated

• Conditions: Breast Neoplasms
• Interventions: Drug: Gadofosveset enhanced MRL of axillary lymph nodes

• Registration Number: NCT01609920
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-06-01
• Status Verified: 2013-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 97

Inclusion Criteria

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

Exclusion Criteria

1. Age <18,
2. Pregnancy
3. Contra indications for MRL such as pacemaker, aneurysm clips or severe claustrophobia.
4. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)
5. Being unable to give informed consent in person
6. Acute or chronic severe renal insufficiency (glomerular filtration rate <45 mL/min/1.73m2)1.
7. Acute renal insufficiency of any severity due to the hepato-renal syndrome.
8. Known (or suspicion of) QT- prolongation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gadofosveset MRL	Gadofosveset enhanced MRL of axillary lymph nodes	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Maastricht University Medical Center (MUMC) AZM; 🇳🇱 Maastricht, Limburg, Netherlands