Characterizing the bone marrow environment in advanced-stage myelofibrosis. A PET/MRI study.
Recruiting
- Conditions
- Myelofibrosis. Myelofibrose.Ruxolitinib.PETMRI
- Registration Number
- NL-OMON20797
- Lead Sponsor
- VU University Medical Center
- Brief Summary
ot applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
A diagnosis of primary MF, post-PV MF or post-ET MF according to the 2008 WHO criteria.
- High- or intermediate-1 or -2 risk level according to the IWG-MRT IPSS criteria
Exclusion Criteria
- Current or previous treatment with a JAK2 inhibitor
- History of allogeneic stem cell transplantation
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A detailed description of the bone marrow environment in advanced-stage myelofibrosis at baseline and during treatment, using the following parameters:<br /><br>- Histopathological findings on bone marrow biopsy<br /><br>- Functional parameters:<br /><br>-- Perfusion (15O-water PET/CT)<br /><br>-- Perfusion/permeability (MRI-DCE)<br /><br>-- Osteoblastic activity (18F-fluoride PET/CT)<br /><br>-- Diffusion restriction (MRI-DWIBS)<br /><br>- Conventional treatment response evaluation according to IWG consensus criteria
- Secondary Outcome Measures
Name Time Method - Exploration of the best imaging technique in diagnosis and response monitoring during ruxolitinib treatment<br /><br>- Explore the degree of sampling error of bone marrow biopsies in myelofibrosis