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

Primary Myelofibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151119
• Other study ID #: XMDYYYXYK-06
• Status: Recruiting
• Start date: November 22, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Bing Xu
• Phone: +8618750918842
• Email: xubingzhangjian[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2025
• Est. primary completion date: October 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Primary Myelofibrosis

Intervention

Diagnostic Test:
• 68Ga FAPI PET/CT
68Ga FAPI PET/CT

Locations

Country	Name	City	State
China	Bing Xu	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.	Up to 24 months
Primary	Specificity	Specificity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.	Up to 24 months
Primary	Positive prediction rate	Positive prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.	Up to 24 months
Primary	Negative prediction rate	Negative prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.	Up to 24 months