Menu
Recruiting NCT06164561

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

— Observational Myelofibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Myelofibrosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • The diagnostic efficiency of 18F-FAPI PET/MRI imaging in myelofibrosis [Time frame: through study completion, an average of 2 years]
Secondary outcome measures (1)
  • Comparison of clinical prognosis between pathological and 18F-FAPI PET/MRI imaging diagnosis by Kappa analysis. [Time frame: through study completion, an average of 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT06164561 · IIT20230329B-R3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗