We hypothesize that by using different imaging techniques, we can give a good characterization of the bone marrow microenvironment in advanced-stage myelofibrosis, before and during treatment with ruxolitinib.
ID
Bron
Verkorte titel
Aandoening
Myelofibrosis. Myelofibrose.
Ruxolitinib.
PET
MRI
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
A detailed description of the bone marrow environment in advanced-stage myelofibrosis at baseline and during treatment, using the following parameters:<br>
- Histopathological findings on bone marrow biopsy<br>
- Functional parameters:<br>
-- Perfusion (15O-water PET/CT)<br>
-- Perfusion/permeability (MRI-DCE)<br>
-- Osteoblastic activity (18F-fluoride PET/CT)<br>
-- Diffusion restriction (MRI-DWIBS)<br>
- Conventional treatment response evaluation according to IWG consensus criteria
Achtergrond van het onderzoek
In myelofibrosis, it is not yet completely understood how the pathologic alterations in the bone marrow environment evolve. After long-term treatment with ruxolitinib – the present standard therapy for patients with advanced-stage myelofibrosis –, regression of marrow fibrosis has been demonstrated in several patients. The currently used diagnostic tool - the bone marrow biopsy – is however not sensitive enough to detect early and functional changes. In this study we aim to gain more insight into the bone marrow microenvironment in advanced-stage myelofibrosis and changes herein during ruxolitinib treatment, by using well-known imaging techniques. More specifically, we will evaluate osteoblastic activity and bone marrow perfusion and – diffusion characteristics using 15O-water-PET, 18F-Fluoride-PET and MRI-DCE and –DWIBS. Furthermore, bone marrow biopsies will be performed in order to assess histopathological response.
Doel van het onderzoek
We hypothesize that by using different imaging techniques, we can give a good characterization of the bone marrow microenvironment in advanced-stage myelofibrosis, before and during treatment with ruxolitinib.
Onderzoeksopzet
At entry, after 6 and 18 months of treatment.
Onderzoeksproduct en/of interventie
Not applicable
Publiek
S. Slot
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
020-4442604 of 020-4444334
s.slot@vumc.nl
Wetenschappelijk
S. Slot
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
020-4442604 of 020-4444334
s.slot@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5127 |
| NTR-old | NTR5259 |
| Ander register | METC VUmc : 2014.479 |