Nodal Staging in Breast Cancer With MRL

• Status: Terminated
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center

Criteria

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