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

Recruiting

• Conditions: Primary Myelofibrosis
• Interventions: Diagnostic Test: 68Ga FAPI PET/CT

• Registration Number: NCT06151119
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-11-21
• Study Start: 2023-11-22
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-11-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-10-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
suspected or confirmed myelofibrosis	68Ga FAPI PET/CT	Patients with suspected or confirmed myelofibrosis;
primary/secondary myelofibrosis	68Ga FAPI PET/CT	Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib.

Primary Outcome Measures

Name	Time	Method
Specificity	Up to 24 months	Specificity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Sensitivity	Up to 24 months	Sensitivity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Negative prediction rate	Up to 24 months	Negative prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Positive prediction rate	Up to 24 months	Positive prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.

Trial Locations

Locations (1)

Bing Xu; 🇨🇳 Xiamen, Fujian, China