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

February 2, 2026 updated by: First Affiliated Hospital of Zhejiang University

18F-FAPI PET/MRI Imaging in the Diagnosis and Monitoring of Therapeutic Effect of 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

myelofibrosis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang Cancer Hospital
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 Provincial Tongde Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jie Sun, MD，Ph.D, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT20230329B-R3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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