Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07419178

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dipartimento di Medicina e Chirurgia

Parma, Italy, Italy, 43126

Actively Recruiting

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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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