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NCT Number: NCT06164561

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

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.

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Key information

Conditions

Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Primary Myelofibrosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location status: Recruiting

Location contact

Jie Sun, MD, Ph.D

CONTACT

[email protected]

+86 153 0571 4109

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The diagnostic efficiency of 18F-FAPI PET/MRI imaging in myelofibrosis

    Time frame: through study completion, an average of 2 years

    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.

Secondary outcomes

  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

    To compare the clinical prognosis between pathological diagnosis and 18F-FAPI PET/MRI diagnosis by Kappa analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Sun, MD，Ph.D

CONTACT

[email protected]

+8615305714109

Jun Zhang, MD

CONTACT

[email protected]

+8615088608182

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

  • First People's Hospital of Hangzhou
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Sir Run Run Shaw Hospital
  • The First Affiliated Hospital of Zhejiang Chinese Medical University
  • Zhejiang Cancer Hospital
  • Zhejiang Provincial Tongde Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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