No registrations found.
ID
Source
Brief title
Health condition
Myelofibrosis. Myelofibrose.
Ruxolitinib.
PET
MRI
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
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.
Study objective
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.
Study design
At entry, after 6 and 18 months of treatment.
Intervention
Not applicable
S. Slot
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
020-4442604 of 020-4444334
s.slot@vumc.nl
S. Slot
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
020-4442604 of 020-4444334
s.slot@vumc.nl
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5127 |
| NTR-old | NTR5259 |
| Other | METC VUmc : 2014.479 |