Breast Neoplasms Clinical Trial
Official title:
Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset
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.
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center (MUMC) AZM | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
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 |
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