MyelofibrosisNCT06164561
18F-FAPI PET/MRI Imaging in Myelofibrosis: a Prospective Observational Study.
An observational study of Myelofibrosis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This study intends to use a prospective, observational, self-controlled, multi-center study design to evaluate the feasibility and diagnostic efficacy of 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging for the evaluation of systemic fibrosis in MF patients based on the results of bone marrow pathological biopsy, and to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myelofibrosis
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2023to 31 Dec 2026
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: myelofibrosis
Who may be able to join
- Patients with primary myelofibrosis or myelofibrosis secondary to myeloid tumors were diagnosed according to the diagnostic criteria of who 2022.
- Stable vital signs, ECOG score ≥ 2 points, tolerate and cooperate to complete 18F-FDG PET/CT and 18F-FAPI PET/MRI examination.
- The interval between imaging ,hematologic, cytogenetic and pathology was < 2 weeks.
- Willing to accept 18F-FDG PET/CT and 18F-FAPI PET/MRI , sign the informed consent.
Who cannot join
- Inability or unwillingness to provide informed consent.
- Other malignancies, autoimmune diseases, or chronic active infections were diagnosed within 1 year before the diagnosis of myelofibrosis.
- Current infection was present within 1 week before PET examination.
- Pregnant or lactation.
- Unable to follow protocol to complete follow-up.
- Have received glucocorticoid therapy within 2 weeks before PET imaging examination.
- Using granulocyte colony-stimulating factor (G-CSF) within 4 weeks prior to PET imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jie Sun, MD, Ph.D, +86 153 0571 4109, jsun1492@zju.edu.cn
About this study
Official title: 18F-FAPI PET/MRI Imaging in the Diagnosis and Monitoring of Therapeutic Effect of Myelofibrosis: a Prospective Observational Study.
This study intends to use a prospective, observational, self-controlled, multi-center study design to evaluate the feasibility and diagnostic efficacy of 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging for the evaluation of systemic fibrosis in MF patients based on the results of bone marrow pathological biopsy, and to analyze the relationship between imaging results and clinical prognosis.
Read the detailed description
Myelofibrosis (MF) is a pathological process characterized by dysplasia of bone marrow fibrous tissue, clonal proliferation of potential stem cells, inflammatory changes in the bone marrow microenvironment, and extramedullary hematopoiesis. Bone marrow histopathology is the gold standard for diagnosis, but because of the invasive nature of the puncture, repeated examination is not possible to dynamically monitor the disease process. In addition, due to the focal nature of puncture biopsy, it can not accurately reflect the systemic disease. 18F-FDG PET/CT provides visual assessment of MF, but its diagnostic effectiveness decreases as MF progresses. 18F-FAPI PET/MRI characterizes fiber activation processes in a variety of diseases. This study intends to use a prospective, observational, self-controlled, multi-center study design to evaluate the feasibility and diagnostic efficacy of 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging for the evaluation of systemic fibrosis in MF patients based on the results of bone marrow pathological biopsy, and to analyze the relationship between imaging results and clinical prognosis.
- Conditions
- Myelofibrosis
- Medical subject headings
- Primary Myelofibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic efficiency of 18F-FAPI PET/MRI imaging in myelofibrosis
The diagnostic efficacy of 18F-FAPI PET/MRI in myelofibrosis was evaluated by visual scoring. The pattern of 18F-FAPI accumulation was analyzed on maximum-intensity projection images for each patient, and the extent of 18F-FAPI accumulation was graded on a 5-point scale（0-4） to assess changes in the extent of bone marrow involvement .The higher of the score, maybe the more severe in the myelofibrosis.The changes in diagnostic efficacy of 18F-FAPI PET/MRI imaging in myelofibrosis were compared with the gold standard of bone marrow biopsy by Kappa analysis.
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
Comparison of clinical prognosis between pathological and 18F-FAPI PET/MRI imaging diagnosis by Kappa analysis.
To compare the clinical prognosis between pathological diagnosis and 18F-FAPI PET/MRI diagnosis by Kappa analysis.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start21 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Cancer Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, First People's Hospital of Hangzhou, Sir Run Run Shaw Hospital
- Responsible party
- Sponsor
- Investigators
- Jie Sun, MD，Ph.D, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164561
- Sponsor's protocol ID
- IIT20230329B-R3
- Status last verified
- Feb 2025
- First submitted
- 23 Nov 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FAPI PET/MRI Imaging in the Diagnosis and Monitoring of Therapeutic Effect of Myelofibrosis: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06164561
- Acronym / sponsor ID
- IIT20230329B-R3
- Conditions
- Myelofibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Cancer Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, First People's Hospital of Hangzhou, Sir Run Run Shaw Hospital
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Dec 2023 (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.
This study intends to use a prospective, observational, self-controlled, multi-center study design to evaluate the feasibility and diagnostic efficacy of 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging for the evaluation of systemic fibrosis in MF patients based on the results of bone marrow pathological biopsy, and to analyze the relationship between imaging results and clinical prognosis.
Detailed description
Myelofibrosis (MF) is a pathological process characterized by dysplasia of bone marrow fibrous tissue, clonal proliferation of potential stem cells, inflammatory changes in the bone marrow microenvironment, and extramedullary hematopoiesis. Bone marrow histopathology is the gold standard for diagnosis, but because of the invasive nature of the puncture, repeated examination is not possible to dynamically monitor the disease process. In addition, due to the focal nature of puncture biopsy, it can not accurately reflect the systemic disease. 18F-FDG PET/CT provides visual assessment of MF, but its diagnostic effectiveness decreases as MF progresses. 18F-FAPI PET/MRI characterizes fiber activation processes in a variety of diseases. This study intends to use a prospective, observational, self-controlled, multi-center study design to evaluate the feasibility and diagnostic efficacy of 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging for the evaluation of systemic fibrosis in MF patients based on the results of bone marrow pathological biopsy, and to analyze the relationship between imaging results and clinical prognosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- myelofibrosis
Key inclusion criteria (4 listed)
- Patients with primary myelofibrosis or myelofibrosis secondary to myeloid tumors were diagnosed according to the diagnostic criteria of who 2022.
- Stable vital signs, ECOG score ≥ 2 points, tolerate and cooperate to complete 18F-FDG PET/CT and 18F-FAPI PET/MRI examination.
- The interval between imaging ,hematologic, cytogenetic and pathology was < 2 weeks.
- Willing to accept 18F-FDG PET/CT and 18F-FAPI PET/MRI , sign the informed consent.
Key exclusion criteria (7 listed)
- Inability or unwillingness to provide informed consent.
- Other malignancies, autoimmune diseases, or chronic active infections were diagnosed within 1 year before the diagnosis of myelofibrosis.
- Current infection was present within 1 week before PET examination.
- Pregnant or lactation.
- Unable to follow protocol to complete follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The diagnostic efficiency of 18F-FAPI PET/MRI imaging in myelofibrosis
Time frame: through study completion, an average of 2 years
The diagnostic efficacy of 18F-FAPI PET/MRI in myelofibrosis was evaluated by visual scoring. The pattern of 18F-FAPI accumulation was analyzed on maximum-intensity projection images for each patient, and the extent of 18F-FAPI accumulation was graded on a 5-point scale（0-4） to assess changes in the extent of bone marrow involvement .The higher of the score, maybe the more severe in the myelofibrosis.The changes in diagnostic efficacy of 18F-FAPI PET/MRI imaging in myelofibrosis were compared with the gold standard of bone marrow biopsy by Kappa analysis.
1 secondary outcome
Comparison of clinical prognosis between pathological and 18F-FAPI PET/MRI imaging diagnosis by Kappa analysis.
Time frame: through study completion, an average of 2 years
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 4 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Jie Sun, MD，Ph.D principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelofibrosis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 4 inclusion and 7 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 4 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 China. 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 Jie Sun, MD，Ph.D (+8615305714109, jsun1492@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic efficiency of 18F-FAPI PET/MRI imaging in myelofibrosis (time frame: through study completion, an average of 2 years). 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 4 Feb 2026.