NL-OMON36702
Completed
Not Applicable
on-invasive nodal staging in breast cancer with MRI Lymphography using gadofosveset; a pilot- study. - Gadofosveset in breast cancer
Medisch Universitair Ziekenhuis Maastricht0 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast cancer
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\. Willing and able to undergo all study procedures
- •4\. 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.
Outcomes
Primary Outcomes
Not specified
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