Status:
RECRUITING
18F-FAPI PET/MRI Imaging in Myelofibrosis: a Prospective Observational Study.
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
Zhejiang Provincial Tongde Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Myelofibrosis
Eligibility:
All Genders
18-80 years
Brief 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 fo...
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 microenviro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT06164561
Start Date
November 21 2023
End Date
December 1 2025
Last Update
April 1 2025
Active Locations (1)
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1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003