NCT07419178

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Sep 2023Apr 2027

Study Start

First participant enrolled

September 5, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

January 29, 2026

Last Update Submit

February 16, 2026

Conditions

Myelofibrosis (MF)

Keywords

C-C chemokine receptor 2Myeloproliferative neoplasmsPETimmunohystochemical assayearly detection of cancerprogression monitoringtherapy response monitoringMRIMRSfluorescence

Outcome Measures

Primary Outcomes (1)

  • Percentage of circulating CD34+/CCR2+ cells

    Percentage of CD34+/CCR2+ cells among total CD34+ cells measured by flow cytometry in peripheral blood samples

    At study enrollment

Secondary Outcomes (3)

  • Bone marrow SUVmax on 68Ga-DOTA-ECL1i PET/CT

    At imaging session

  • Volume of active bone marrow on 68Ga-DOTA-ECL1i PET/CT

    At imaging session

  • Tracer uptake in extramedullary sites

    At imaging session

Study Arms (1)

MPN subtypes

EXPERIMENTAL

Patient will be tested for CCR2 expression on CD34+ cells in order to correlate imaging and flow-cytometry data.

Diagnostic Test: Diagnosis of MPN subtypes

Interventions

Diagnosis of MPN subtypesDIAGNOSTIC_TEST

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

MPN subtypes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy/breastfeeding
  • Ongoing therapy with immunomodulatory drugs (JAK-inhibitors, interferon).
  • For PET imaging, patients should be off any cytoreductive treatment for at least 3 months.
  • Antiplatelet agents are allowed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dipartimento di Medicina e Chirurgia

Parma, Italy, 43126, Italy

RECRUITING

MeSH Terms

Conditions

Primary MyelofibrosisMyeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Elena Masselli, MD, PhD

CONTACT

+39 0521 906655elena.masselli@unipr.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 18, 2026

Study Start

September 5, 2023

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)