68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.

February 18, 2025 updated by: Bing, Xu, The First Affiliated Hospital of Xiamen University

A Study to Evaluate 68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.

To evaluate the diagnostic efficacy of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.

To evaluate the diagnostic efficacy of 68Ga FAPIPET/CT imaging in patients with myelofibrosis, compared with conventional CT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study uses bone marrow biopsy as a gold standard or reference standard to evaluate the diagnostic efficacy (Sensitivity, Specificity, Positive prediction rate, Negative prediction rate) of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.

Study Type

Observational

Enrollment (Estimated)

90

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 Backup

Study Locations

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Chinese people

Description

Inclusion Criteria:

  1. Age ≥18 years old;
  2. Cohort 1: Patients with suspected or confirmed myelofibrosis; Cohort 2: Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib.
  3. The expected survival time is over 3 months
  4. Voluntarily sign informed consent.
  5. Willing and able to follow the research protocol;
  6. The subject must be able to lie on the scanning bed for 20 minutes;

Exclusion Criteria:

  1. Known allergic history to 68Ga FAPI or its excipients;
  2. Patients who can not tolerate intravenous drug administration (such as needle fainting and blood fainting history);
  3. Those who are not suitable for or unable to complete imaging tests such as PET due to special reasons, including claustrophobia and radiophobia;
  4. pregnant and lactating women;
  5. Workers who are exposed to radiation for a long period of time;
  6. Serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis/cirrhosis;
  7. Participating in other interventional clinical trials within 1 month before screening;
  8. Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy due to other cancers;
  9. There are other circumstances that the researcher thinks are not suitable for participating in this study;

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
suspected or confirmed myelofibrosis
Patients with suspected or confirmed myelofibrosis;
Diagnostic test: 68Ga FAPI PET/CT
68Ga FAPI PET/CT
primary/secondary myelofibrosis
Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib.
Diagnostic test: 68Ga FAPI PET/CT
68Ga FAPI PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Up to 24 months
Sensitivity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Up to 24 months
Specificity
Time Frame: Up to 24 months
Specificity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Up to 24 months
Positive prediction rate
Time Frame: Up to 24 months
Positive prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Up to 24 months
Negative prediction rate
Time Frame: Up to 24 months
Negative prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Up to 24 months

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Xiamen University

Investigators

  • Principal Investigator: Bing Xu, The First Aiffiliated hosptical of xiamen 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)

November 22, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMDYYYXYK-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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