Clinical trial NCT06164561: 18F-FAPI PET/MRI Imaging in Myelofibrosis: a Prospective Observational Study.
Official title: 18F-FAPI PET/MRI Imaging in the Diagnosis and Monitoring of Therapeutic Effect of Myelofibrosis: a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myelofibrosis
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Tongde Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Zhejiang Cancer Hospital
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: First People's Hospital of Hangzhou
name: Sir Run Run Shaw Hospital
First posted: 2023-12-11
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: myelofibrosis

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 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.

Eligibility 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.

Primary outcomes:
measure: The diagnostic efficiency of 18F-FAPI PET/MRI imaging in myelofibrosis
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Comparison of clinical prognosis between pathological and 18F-FAPI PET/MRI imaging diagnosis by Kappa analysis.
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Jie Sun, MD，Ph.D
role: PRINCIPAL_INVESTIGATOR
References: