18F-FAPI PET/MRI Imaging in Myelofibrosis: a Prospective Observational Study.

Myelofibrosis Clinical Trial

Official title:

18F-FAPI PET/MRI Imaging in the Diagnosis and Monitoring of Therapeutic Effect of Myelofibrosis: a Prospective Observational Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164561
• Other study ID #: IIT20230329B-R3
• Status: Recruiting
• Start date: November 21, 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Jie Sun, MD,Ph.D
• Phone: +8615305714109
• Email: jsun1492[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 analyze the relationship between imaging results and clinical prognosis.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myelofibrosis
• Primary Myelofibrosis

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (7)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	First People's Hospital of Hangzhou, Run Run Shaw Hospital Affiliated to Medical College of Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University, The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Cancer Hospital, Zhejiang Provincial Tongde Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 2 years
Secondary	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.	through study completion, an average of 2 years