Nodal Staging in Breast Cancer With MRL
Information source: Maastricht University Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Neoplasms
Intervention: Gadofosveset enhanced MRL of axillary lymph nodes (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Maastricht University Medical Center Official(s) and/or principal investigator(s):
R.G.H. Beets-Tan, MD, PhD, Principal Investigator, Affiliation: Maastricht University Medical Center
Overall contact:
Robert-Jan Schipper, MD, Phone: 003143381575, Email: robertjan.schipper@mumc.nl
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.
Clinical Details
Official title: Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Robert-Jan Schipper, MD, Phone: 003143381575, Email: robertjan.schipper@mumc.nl
Maastricht University Medical Center (MUMC) AZM, Maastricht, Limburg 6225 HX, Netherlands; Recruiting
Robert-Jan Schipper, MD, Phone: 003143381575, Email: robertjan.schipper@mumc.nl
R.G.H. Beets-Tan, MD, PhD, Principal Investigator
Additional Information
Starting date: May 2012
Last updated: June 6, 2012
|
