Using advanced imaging to evaluate myelofibrosis
18F-FAPI PET/MRI Imaging in the Diagnosis and Monitoring of Therapeutic Effect of Myelofibrosis: a Prospective Observational Study.
This study is testing new imaging techniques to see if they can help doctors better understand and monitor myelofibrosis without needing invasive procedures like bone marrow biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 57 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06164561 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility and diagnostic effectiveness of 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging in patients with myelofibrosis. By comparing imaging results with bone marrow biopsy findings, the study seeks to provide insights into the relationship between imaging outcomes and clinical prognosis. The study design is multi-center and self-controlled, allowing for a comprehensive evaluation of systemic fibrosis in myelofibrosis patients. The goal is to improve non-invasive monitoring of the disease process.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with primary or secondary myelofibrosis who can tolerate imaging procedures.
Not a fit: Patients with other malignancies, autoimmune diseases, or those currently infected may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved non-invasive diagnostic methods for monitoring myelofibrosis.
How similar studies have performed: While the use of PET imaging in myelofibrosis is emerging, this specific approach with 18F-FAPI PET/MRI is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jie Sun, MD，Ph.D — Zhejiang University
- Study coordinator: Jie Sun, MD，Ph.D
- Email: jsun1492@zju.edu.cn
- Phone: +8615305714109
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.