Status:
COMPLETED
Gadofosveset for Axillary Staging in Breast Cancer Patients
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ma...
Eligibility Criteria
Inclusion
- Patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging.
- Tumor must be a T2 according the TNM 6-classification.
- The ultrasound of the axilla must be suspect for nodal metastases.
- Willing and able to undergo all study procedures
- Has personally provided written informed consent.
Exclusion
- Age \<18
- History of prior chemotherapy
- History of prior radiotherapy of the surrounding areas of the axilla.
- Pregnancy
- Contra indications for MRI 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 \<30 mL/min/1.73m2).
- Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01437865
Start Date
September 1 2011
End Date
March 1 2012
Last Update
April 6 2012
Active Locations (1)
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1
Maastricht University Medical Center (MUMC) AZM
Maastricht, Netherlands