Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study
1. Patient with histopathologically confirmed invasive breast cancer about to undergo
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.
1. Age <18
2. History of prior chemotherapy
3. History of prior radiotherapy of the surrounding areas of the axilla.
5. Contra indications for MRI such as pacemaker, aneurysm clips or severe
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
9. Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the
perioperative liver transplantation period.
Type of Study:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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.
Outcome Time Frame:
Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.
R. Beets - Tan, MD, PhD
Maastricht University Medical Center
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
- Breast Neoplasms
- lymph node metastases
- breast cancer
- Breast Neoplasms