Ferumoxytol as an MR contrast agent in CNS and head & neck tumors, intracranial and peripheral vascular disease

Diagnostic Centre of Pécs0 sitesJuly 27, 2015

Overview

No summary available.

Registry

who.int

Start Date

July 27, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Diagnostic Centre of Pécs

•Group specific inclusion criteria
•Group 1: Radiologic or histologic diagnosis of inflammatory, vascular, ischemic or demyelinizating disease of the central nervous system
•Group 2: Subjects must have a known or presumed radiological diagnosis of glioma or other malignant CNS disease. For presumed diagnosis of GBM, histological confirmation of GBM must be completed within 12 weeks of enrollment.
•Group 3: Subjects must have clinical or radiological diagnosis of enlarged cervical lymph nodes
•Group 4: Subjects must have presumed clinical or radiological diagnosis of peripheral vascluar disease
•Non\-group specific inclusion criteria:
•Subjects must be between 18 and 80 year old for inclusion in this study.
•All subjects, or their legal guardians, must sign a written informed consent in accordance with institutional guidelines.
•Subjects with a calculated GFR \> 60 mL/min/1\.73 m2 . (Calculation must be done using the National Kidney Disease Education Program’s website http://nkdep.nih.gov/lab\-evaluation/gfr\-calculators/adults\-conventional\-unit.asp )
•Subjects must have a Karnofsky of 30% or greater.

•1\.Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible.
•2\.Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron\-dextran, or parenteral iron\-polysaccharide preparations (Ferumoxytol Investigator’s Drug Brochure, 2009\). Subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator’s discretion.
•3\.Subjects who are pregnant or lactating or who suspect they might be pregnant.
•4\.Subjects who have a contraindication for 3T MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material.
•5\.Subjects with known iron overload (genetic hemochromatosis). In subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: Transferrin saturation (TS) test and Serum ferritin (SF) test. All associated costs will be paid by the study.
•6\.Subject who have received ferumoxytol within 3 weeks of study entry.
•7\. HIV\-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol.