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Nodal Staging in Breast Cancer With MRL

Information source: Maastricht University Medical Center
ClinicalTrials.gov processed this data on November 27, 2014
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 (VasovistĀ® /AblavarĀ®) 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: May 13, 2013

Page last updated: November 27, 2014

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