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RECRUITING
NCT07419178
NA

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

Sponsor: Azienda Ospedaliero-Universitaria di Parma

View on ClinicalTrials.gov

Summary

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

265

Start Date

2023-09-05

Completion Date

2027-04-30

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Diagnosis of MPN subtypes

Non-invasive imaging method (PET/CT) and flow-cytometry

Locations (1)

Dipartimento di Medicina e Chirurgia

Parma, Italy, Italy