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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20797

Enrollment

Registered

2015-06-19

Start date

2015-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Myelofibrosis. Myelofibrose. Ruxolitinib. PET MRI

Interventions

None listed

Eligibility

Inclusion criteria

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 - High grade fibrosis (grade 3 or 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 < 50,000/µL) - Contraindication for used imaging modalities - Inability to sign informed consent

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 on bone marrow biopsy - Functional parameters: -- Perfusion (15O-water PET/CT) -- Perfusion/permeability (MRI-DCE) -- Osteoblastic activity (18F-fluoride PET/CT) -- Diffusion restriction (MRI-DWIBS) - Conventional treatment response evaluation according to IWG consensus criteria	—

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 on bone marrow biopsy - Functional parameters: -- Perfusion (15O-water PET/CT) -- Perfusion/permeability (MRI-DCE) -- Osteoblastic activity (18F-fluoride PET/CT) -- Diffusion restriction (MRI-DWIBS) - Conventional treatment response evaluation according to IWG consensus criteria

—

Secondary

Measure	Time frame
- Exploration of the best imaging technique in diagnosis and response monitoring during ruxolitinib treatment - Explore the degree of sampling error of bone marrow biopsies in myelofibrosis	—

Contacts

Public ContactS. Slot

PK2BR002

s.slot@vumc.nl020-4442604 of 020-4444334

Outcome results