Actively Recruiting
A New Diagnostic Algorithm to Non-invasively Track Fibrotic Changes in Myeloproliferative Neoplasms Based on CCR2 Detection Using Flow Cytometry and Targeted PET Molecular Imaging
Led by Azienda Ospedaliero-Universitaria di Parma · Updated on 2026-02-18
265
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying chronic Philadelphia-negative myeloproliferative syndromes, which are blood disorders including essential thrombocythemia, polycythemia vera, and myelofibrosis. Myelofibrosis may occur initially or develop from the other conditions and is marked by scar-like tissue in the bone marrow, indicating a more severe disease stage. Currently, bone marrow biopsy is the only way to assess this fibrosis, and the study aims to find less invasive methods by tracking cells expressing the CCR2 receptor, a marker of fibrosis. The study evaluates a new diagnostic approach using flow cytometry on blood samples to identify CCR2-positive cells and PET-CT imaging with a targeted tracer called 68Ga-DOTA-ECL1i that binds to these cells. This approach is being tested both in preclinical models and in patients with myeloproliferative neoplasms. The project includes tracking these cells for diagnosis, functional imaging in mice, and imaging in human participants to support diagnosis and monitoring. Participants will have their blood tested for CCR2 expression on certain cells and undergo PET-CT imaging sessions using the tracer. Researchers will measure the percentage of circulating CD34+/CCR2+ cells as the main outcome and assess bone marrow activity and tracer uptake in other sites during imaging. The study supports diagnosis and disease monitoring without invasive biopsies and includes follow-up assessments to understand fibrotic progression. Participation involves blood tests and imaging, with evaluations done at enrollment and imaging sessions.
CONDITIONS
Brief 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 essential thrombocythemia, polycythemia vera, pre-primary myelofibrosis, overt primary myelofibrosis, or secondary myelofibrosis 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, not having stopped cytoreductive treatment for at least 3 months
- Antiplatelet agents are allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 day
Participants undergo non-invasive imaging using PET/CT and flow cytometry to assess CCR2 expression on CD34+ cells and correlate imaging and blood data for diagnosis of MPN subtypes.
1 imaging and blood sample collection visit (in-person)
Duration - Up to study completion
Participants are observed over time to track disease progression and support clinical decisions without invasive procedures.
Follow-up visits as needed depending on clinical assessment
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
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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