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van CCT (UK)


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


- candidate number22366
- NTR NumberNTR5259
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jun-2015
- Secondary IDs2014.479 METC VUmc
- Public TitleCharacterizing the bone marrow environment in advanced-stage myelofibrosis. A PET/MRI study.
- Scientific TitleCharacterizing the bone marrow environment in advanced-stage myelofibrosis. A PET/MRI study.
- ACRONYMBEAMY
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedMyelofibrosis, MRI, PET scan
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2015
- planned closingdate1-apr-2016
- Target number of participants6
- InterventionsNot applicable
- Primary outcomeA 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
- TimepointsAt entry, after 6 and 18 months of treatment.
- Trial web siteNot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc S. Slot
- CONTACT for SCIENTIFIC QUERIESMSc S. Slot
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Novartis Pharma B.V.
- PublicationsNot applicable
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD19-jun-2015 - 16-aug-2015


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