Actively Recruiting
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
Led by Azienda Ospedaliero-Universitaria di Parma · Updated on 2026-02-18
265
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ET, PV, pre-primary myelofibrosis, overt primary myelofibrosis, or secondary myelofibrosis according to official criteria with histopathological data
- Age 18 years or older
- ECOG performance status of 3 or less
You will not qualify if you...
- Pregnancy or breastfeeding
- Current treatment with immunomodulatory drugs such as JAK-inhibitors or interferon
- For PET imaging, must be off cytoreductive treatment for at least 3 months
- Antiplatelet agents are allowed
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dipartimento di Medicina e Chirurgia
Parma, Italy, Italy, 43126
Actively Recruiting
Research Team
E
Elena Masselli, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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