Feraheme will be tested as an MRI contrast agent in the diseases of the central nervous system, in head and neck tumors and peripheral vascular diseases.
Conditions
Interventions
Trade Name: Feraheme
Pharmaceutical Form: Infusion
Sponsors
Diagnostic Centre of Pécs
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of the study is to test ferumoxytol as an MR contrast agent for imaging various diseases in the head and neck region, spine, including the central nervous system, in order to better understand the underlying cellular mechanisms, contrast agent extravasation, uptake into macrophages and to assess its value in clinical MR imaging. Besides this, the purpose of the study isto test the clinical value of high resolution steady state CBV maps. Since the potential clinical benefit of this new technique is due to its higher spatial resolution and distortion free parametric maps, the primary objective is to investigate the superiority of SS-CBV mapping over DSC-CBV in visualizing highly vascularized tumor areas. ;Secondary Objective: Secondary objectives include optimizing MR sequences and ferumoxytol injections to obtain absolute CBV values for steady state imaging and testing the association between rCBV and survival, the ability differentiating between progression and pseudoprogression, as well as histological correlation. We will also assess the delayed ferumoxytol enhancement in various stages of disease.;Primary end point(s): The primary endpoints include four visualization variables to compare ferumoxytol vs gadolinium enhanced MRI scans and SS-CBV maps vs. DSC-CBV maps. ;Timepoint(s) of evaluation of this end point: The MRI scans are going to be assessed continuously during the study. Statistical analysis is going to be performed after reaching the optimal subject number. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints include overall survival, rCBV values and ferumoxytol enhancement 24h after administration assessed at different disease stages. ;Timepoint(s) of evaluation of this end point: The start observation time for overall survival will be the date of diagnosis. | — |
Countries
Hungary
Contacts
Public ContactClinical Trials Information
Diagnostic Centre of Pécs
Outcome results
None listed