CCR2-based blood test and PET imaging to detect bone marrow fibrosis in myeloproliferative neoplasms
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
This project tests whether a blood test measuring CCR2-positive cells and a CCR2-targeted PET scan can find and track bone marrow fibrosis in adults with myeloproliferative neoplasms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 265 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria di Parma Academic / other |
| Locations | 1 site (Parma, Italy) |
| Trial ID | NCT07419178 on ClinicalTrials.gov |
What this trial studies
The project will measure CD34+CCR2+ cells in peripheral blood by flow cytometry and develop a CCR2-targeted PET tracer to image fibrotic bone marrow non-invasively. Work combines preclinical validation and a first-in-human proof-of-concept imaging approach. The goal is a diagnostic algorithm that uses blood and imaging biomarkers to identify fibrotic progression without routine bone marrow biopsy. The approach is intended for use at diagnosis, during follow-up for suspected progression, or when biopsy is contraindicated.
Who should consider this trial
Good fit: Adults (≥18 years) with Philadelphia-negative myeloproliferative neoplasms (ET, PV, prePMF, overt PMF or SMF with histopathology), ECOG ≤3, and not currently on immunomodulatory drugs; PET participants should be off cytoreductive therapy for at least three months.
Not a fit: Patients who are pregnant or breastfeeding, those on JAK inhibitors or interferon, those unable to pause cytoreductive therapy for PET, or with contraindications to PET/CT are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could allow earlier, non-invasive detection and monitoring of marrow fibrosis, reducing the need for repeat bone marrow biopsies and helping guide treatment decisions.
How similar studies have performed: Preclinical data support CCR2 as a fibrosis biomarker and some early imaging work exists, but CCR2-targeted PET for tracking marrow fibrosis is largely novel and this includes first-in-human proof-of-concept work.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Parma, Italy
- Dipartimento di Medicina e Chirurgia — Parma, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Elena Masselli, MD, PhD
- Email: elena.masselli@unipr.it
- Phone: +39 0521 906655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.