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

NCT06164561 | Recruiting DMC

• 1 other identifier: IIT20230329B-R3
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of clinical prognosis between pathological and 18F-FAPI PET/MRI imaging diagnosis by Kappa analysis.

  through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

myelofibrosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jie Sun, MD，Ph.D

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Sun, MD，Ph.D

CONTACT

+8615305714109; jsun1492@zju.edu.cn

Jun Zhang, MD

CONTACT

+8615088608182; zj801008@aliyun.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 11, 2023
• Study Start: November 21, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2025-02

Locations

CN (1)