Clinical trial · Interventional
A New Diagnostic Algorithm to Non-invasively Track Fibrotic Changes in Myeloproliferative Neoplasms Based on C-C Chemokine Receptor 2 Detection. From Flow Cytometry to the Development of Targeted Positron Emission Tomography Molecular Imaging. Pre-clinical Studies and First In-human Proof of Concept
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Chronic "Philadelphia-negative" myeloproliferative syndromes are chronic blood disorders. They include essential thrombocythemia, polycythemia vera, and myelofibrosis. Myelofibrosis may arise de novo ("primary myelofibrosis") or represent the evolution of essential thrombocythemia or polycythemia vera ("secondary myelofibrosis"). The myelofibrotic stage-characterized, as the name implies, by the presence of bone marrow fibrosis (deposition of scar-like tissue)-is generally associated with a more severe and symptomatic disease. To date, the only way to assess fibrotic progression in these disorders is bone marrow biopsy. The aim of this project is to evaluate whether the identification, tracking, and quantification of cells expressing a specific receptor (CCR2), a selective biomarker of fibrosis, may allow early and non-invasive identification of the fibrotic stage of the disease through: * laboratory analysis on a blood sample (using flow cytometry) * use in PET-CT (positron emission tomography combined with computed tomography) of a tracer specific for the CCR2 receptor, capable of selectively binding to CCR2-expressing cells (⁶⁸Ga-DOTA-ECL1i).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelofibrosis (MF) | Primary Myelofibrosis | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnosis of MPN subtypes | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MPN subtypes
- description
- Patient will be tested for CCR2 expression on CD34+ cells in order to correlate imaging and flow-cytometry data.
- interventionNames
- Diagnostic Test: Diagnosis of MPN subtypes
Primary outcomes (1)
- measure
- Percentage of circulating CD34+/CCR2+ cells
- timeFrame
- At study enrollment
- description
- Percentage of CD34+/CCR2+ cells among total CD34+ cells measured by flow cytometry in peripheral blood samples
Secondary outcomes (3)
- measure
- Bone marrow SUVmax on 68Ga-DOTA-ECL1i PET/CT
- timeFrame
- At imaging session
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of ET/PV/prePMF/overtPMF according to the WHO 2016 criteria and of SMF according to the IWG-MRT criteria (with histopathological data). * Age \>= 18 yrs * ECOG performance status \<=3 Exclusion Criteria: * Pregnancy/breastfeeding * Ongoing therapy with immunomodulatory drugs (JAK-inhibitors, interferon). * For PET imaging, patients should be off any cytoreductive treatment for at least 3 months. * Antiplatelet agents are allowed
References
Publications (0)
Data not yet available