Actively Recruiting
18F-FAPI PET/MRI Imaging in the Diagnosis and Monitoring of Therapeutic Effect of Myelofibrosis: a Prospective Observational Study.
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-02-04
57
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
Z
Zhejiang Provincial Tongde Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying myelofibrosis (MF), a disease involving abnormal bone marrow fibrosis, stem cell growth, and inflammation, which is difficult to monitor due to invasive biopsy methods. This observational study aims to assess the usefulness and accuracy of two imaging techniques, 18F-FDG PET/CT and 18F-FAPI PET/MRI, in evaluating systemic fibrosis in MF patients. The study will also explore how these imaging results relate to patients' clinical outcomes. Participants diagnosed with primary or secondary myelofibrosis will undergo both 18F-FDG PET/CT and 18F-FAPI PET/MRI scans. The study design is prospective, observational, self-controlled, and conducted across multiple centers. Imaging, hematologic, cytogenetic, and pathological assessments will be performed within two weeks of each other. Patients must be stable and able to cooperate with the imaging procedures. During the study, participants will be monitored over an average of two years to evaluate the diagnostic performance of 18F-FAPI PET/MRI and compare clinical prognoses based on imaging and pathology results. The study will include assessments such as imaging scans and clinical follow-up. Safety and adherence to protocol will be tracked, with informed consent required. The goal is to improve noninvasive monitoring of myelofibrosis progression and treatment effects.
CONDITIONS
Brief Title
18F-FAPI PET/MRI Imaging in Myelofibrosis: a Prospective Observational Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with primary myelofibrosis or myelofibrosis secondary to myeloid tumors according to WHO 2022 criteria
- Stable vital signs and an ECOG score of 2 or higher
- Able and willing to complete 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging
- Imaging, hematologic, cytogenetic, and pathology tests performed within 2 weeks of each other
- Willing to accept the imaging procedures and provide informed consent
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Diagnosed with other malignancies, autoimmune diseases, or chronic active infections within 1 year before myelofibrosis diagnosis
- Current infection within 1 week before PET imaging
- Pregnant or breastfeeding
- Unable to complete follow-up according to the study protocol
- Received glucocorticoid therapy within 2 weeks before PET imaging
- Used granulocyte colony-stimulating factor (G-CSF) within 4 weeks before PET imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 2 weeks
Participants undergo 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging to assess systemic fibrosis associated with myelofibrosis.
1 to 2 imaging visits
Duration - Up to 2 years
Participants are observed for clinical prognosis and disease progression over time, correlating imaging results with clinical outcomes.
Follow-up visits as scheduled over 2 years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
J
Jie Sun, MD，Ph.D
J
Jun Zhang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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