Nodal Staging in Breast Cancer With MRL

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01609920
• Other study ID #: 12-2-032
• Status: Terminated
• Phase: N/A
• First received: May 30, 2012
• Last updated: November 9, 2016
• Start date: May 2012
• Est. completion date: May 2016

Study information

• Verified date: May 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Gadofosveset enhanced MRL of axillary lymph nodes
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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center (MUMC) AZM	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.	No