Gadofosveset for Axillary Staging in Breast Cancer Patients

Breast Neoplasms Clinical Trial

Official title:

Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437865
• Other study ID #: 11-2-016
• Status: Completed
• Phase: N/A
• First received: September 12, 2011
• Last updated: April 5, 2012
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Gadofosveset contrast agent enhanced MRI Axilla
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.

Locations

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

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 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.	Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.	No