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NCT07419178Recruiting

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 · Last updated 18 Feb 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
265 (estimated)
First submitted
29 Jan 2026
Start date
5 Sept 2023
Primary completion date
28 Feb 2027
Lead sponsor
Azienda Ospedaliero-Universitaria di Parma
NCT number
NCT07419178

What you commit to

  • Study type: Interventional
  • Planned participants: 265
  • From 5 Sept 2023 to the primary completion date, 28 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Ongoing therapy with immunomodulatory drugs (JAK-inhibitors, interferon).

Other

  • Pregnancy/breastfeeding
  • For PET imaging, patients should be off any cytoreductive treatment for at least 3 months.
  • Antiplatelet agents are allowed

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dipartimento di Medicina e Chirurgia
Coordinator of this site? Confirm its status
ParmaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.