Characterizing the bone marrow environment in advanced-stage myelofibrosis. A PET/MRI study.

Completed

Conditions: bone marrow fibrosis
Myelofibrosis
10018865

Registration Number: NL-OMON43646

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

• A diagnosis of primary-, post-polycythemia vera- or post-essential thrombocythemia MF (according to the 2008 WHO criteria)
• A high- or intermediate-1 or -2 risk level (according to the IWG-MRT DIPSS criteria)
• Fibrosis (grade 2-4) on bone marrow biopsy
• A scheduled treatment with (and thus an indication and eligibility for) ruxolitinib

Exclusion Criteria

• Current or previous treatment with a JAK2 inhibitor
• History of allogeneic stem cell transplantation
• Contraindication for treatment with ruxolitinib (including a platelet count < 50,000/µL)
• Contraindication for used imaging modalities
• Inability to sign informed consent

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A detailed description of the bone marrow environment in advanced stage<br /><br>myelofibrosis at baseline and during treatment, using the following parameters:<br /><br>• Histopathological findings (cellularity, morphology of hematopoietic cells,<br /><br>reticulin and collagen fibrosis, osteosclerosis, vascularity, dilatation of<br /><br>sinusoids) on bone marrow biopsy as scored by the local pathologist<br /><br>• Functional parameters:<br /><br>o Perfusion as determined by 15O -water-PET/CT<br /><br>o Perfusion/permeability as determined with MRI-DCE<br /><br>o Osteoblastic activity as determined by 18F -fluoride-PET/CT<br /><br>o Diffusion restriction as determined by MRI-DWIBS<br /><br>• Conventional treatment response evaluation (reduction in constitutional<br /><br>symptoms / total symptom score (MPN-SAF), reduction of hepatosplenomegaly,<br /><br>improvement in blood hematology values, JAK2 allelic burden and bone marrow<br /><br>abnormalities).</p><br>

Secondary Outcome Measures