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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43646

Enrollment

Registered

2014-12-17

Start date

2015-07-02

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bone marrow fibrosis Myelofibrosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results