Myelofibrosis (MF)GR-MPNNCT07419178
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
A study testing Diagnosis of MPN subtypes in people with Myelofibrosis (MF), run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis (MF)
- What is being tested?
- Diagnosis of MPN subtypes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Dipartimento di Medicina e Chirurgia
Parma, Italy, 43126
Elena Masselli, MD, PhD, +39 0521 906655, elena.masselli@unipr.it
About this study
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.
Read more
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).
Read the detailed description
It is well established that the presence of bone marrow fibrosis in Philadelphia-negative myeloproliferative neoplasms (MPNs) defines a more severe disease stage, with a worse prognosis and a high risk of leukemic transformation. Therefore, accurate allocation of each patient to the correct diagnostic category is essential for subsequent therapeutic planning, which may also include bone marrow transplantation for selected patients.
To date, the only method available to assess bone marrow fibrosis is histopathological analysis of the bone marrow, which inevitably requires an invasive procedure such as bone marrow biopsy.
The aim of this project is to evaluate whether tracking and quantification of CD34⁺CCR2⁺ cells through flow cytometry (FCM) on peripheral blood and functional imaging may represent a valid non-invasive tool for identifying the fibrotic stage of the disease, thus supporting clinicians at key diagnostic time points, such as:
At disease onset, in support of histopathology for differential diagnosis when morphological features alone may be ambiguous (e.g., ET vs prePMF, unclassifiable MPNs); During follow-up, in cases of suspected progression of ET/PV to secondary myelofibrosis (SMF), as a screening tool prior to bone marrow biopsy; As an alternative to bone marrow biopsy, when clinical conditions do not allow the procedure.
To this end, the project is structured around the following AIMS:
AIM 1 - Tracking of CD34⁺CCR2⁺ cells by flow cytometry as a diagnostic tool supporting histopathology in the differential diagnosis of MPN subtypes.
AIM 2 - Functional imaging of CCR2⁺ cells using the radioligand ⁶⁸Ga-DOTA-ECL1i in a murine model of myelofibrosis.
AIM 3 - Functional imaging of CCR2⁺ cells using the radioligand ⁶⁸Ga-DOTA-ECL1i in patients affected by MPNs.
- Conditions
- Myelofibrosis (MF)
- Being tested
- Diagnosis of MPN subtypes
- Keywords
- C-C chemokine receptor 2, Myeloproliferative neoplasms, PET, immunohystochemical assay, early detection of cancer, progression monitoring, therapy response monitoring, MRI, MRS, fluorescence
- Medical subject headings
- Primary Myelofibrosis, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of MPN subtypesDiagnostic test
Non-invasive imaging method (PET/CT) and flow-cytometry
| Study group | Role | What they receive |
|---|---|---|
| MPN subtypes | Experimental | Patient will be tested for CCR2 expression on CD34+ cells in order to correlate imaging and flow-cytometry data. Receives: Diagnostic Test: Diagnosis of MPN subtypes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of circulating CD34+/CCR2+ cells
Percentage of CD34+/CCR2+ cells among total CD34+ cells measured by flow cytometry in peripheral blood samples
Measured: At study enrollment
Secondary outcomes (3)
Bone marrow SUVmax on 68Ga-DOTA-ECL1i PET/CT
Maximum standardized uptake value (SUVmax) of 68Ga-DOTA-ECL1i in bone marrow regions measured by PET/CT imaging
Measured: At imaging session
Volume of active bone marrow on 68Ga-DOTA-ECL1i PET/CT
Volume of interest with tracer uptake above mean liver uptake plus two standard deviations measured by PET/CT imaging
Measured: At imaging session
Tracer uptake in extramedullary sites
Standardized uptake value and signal-to-background ratio of 68Ga-DOTA-ECL1i in extramedullary sites measured by PET/CT imaging
Measured: At imaging session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start5 Sep 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelofibrosis (MF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Masselli, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419178
- Sponsor's protocol ID
- 66/2023/SPER/AOUPR
- Other IDs
- GR-2021-12373308
- Acronym
- GR-MPN
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07419178
- Acronym / sponsor ID
- GR-MPN / 66/2023/SPER/AOUPR
- Conditions
- Myelofibrosis (MF)
- Keywords
- C-C chemokine receptor 2, Myeloproliferative neoplasms, PET, immunohystochemical assay, early detection of cancer, progression monitoring, therapy response monitoring, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
It is well established that the presence of bone marrow fibrosis in Philadelphia-negative myeloproliferative neoplasms (MPNs) defines a more severe disease stage, with a worse prognosis and a high risk of leukemic transformation. Therefore, accurate allocation of each patient to the correct diagnostic category is essential for subsequent therapeutic planning, which may also include bone marrow transplantation for selected patients.
To date, the only method available to assess bone marrow fibrosis is histopathological analysis of the bone marrow, which inevitably requires an invasive procedure such as bone marrow biopsy.
The aim of this project is to evaluate whether tracking and quantification of CD34⁺CCR2⁺ cells through flow cytometry (FCM) on peripheral blood and functional imaging may represent a valid non-invasive tool for identifying the fibrotic stage of the disease, thus supporting clinicians at key diagnostic time points, such as:
At disease onset, in support of histopathology for differential diagnosis when morphological features alone may be ambiguous (e.g., ET vs prePMF, unclassifiable MPNs); During follow-up, in cases of suspected progression of ET/PV to secondary myelofibrosis (SMF), as a screening tool prior to bone marrow biopsy; As an alternative to bone marrow biopsy, when clinical conditions do not allow the procedure.
To this end, the project is structured around the following AIMS:
AIM 1 - Tracking of CD34⁺CCR2⁺ cells by flow cytometry as a diagnostic tool supporting histopathology in the differential diagnosis of MPN subtypes.
AIM 2 - Functional imaging of CCR2⁺ cells using the radioligand ⁶⁸Ga-DOTA-ECL1i in a murine model of myelofibrosis.
AIM 3 - Functional imaging of CCR2⁺ cells using the radioligand ⁶⁸Ga-DOTA-ECL1i in patients affected by MPNs.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPN subtypes | Experimental | Diagnostic Test: Diagnosis of MPN subtypesPatient will be tested for CCR2 expression on CD34+ cells in order to correlate imaging and flow-cytometry data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of MPN subtypesNon-invasive imaging method (PET/CT) and flow-cytometry | Diagnostic test | MPN subtypes |
Primary outcome
Percentage of circulating CD34+/CCR2+ cells
Time frame: At study enrollment
Percentage of CD34+/CCR2+ cells among total CD34+ cells measured by flow cytometry in peripheral blood samples
3 secondary outcomes
Bone marrow SUVmax on 68Ga-DOTA-ECL1i PET/CT
Time frame: At imaging session
Volume of active bone marrow on 68Ga-DOTA-ECL1i PET/CT
Time frame: At imaging session
Tracer uptake in extramedullary sites
Time frame: At imaging session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosis of MPN subtypes in people with Myelofibrosis (MF), run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Masselli, MD, PhD (+39 0521 906655, elena.masselli@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of circulating CD34+/CCR2+ cells (time frame: At study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.