Breast Neoplasms
Conditions
Keywords
MRI, lymph node metastases, breast cancer, gadofosveset
Brief 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.
Interventions
DRUGGadofosveset 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.
Sponsors
Maastricht University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases | Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks. | 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. |
Countries
Netherlands
Outcome results
None listed