Status:
RECRUITING
68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Primary Myelofibrosis
Eligibility:
All Genders
18+ years
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...
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 F...
Eligibility Criteria
Inclusion
- Age ≥18 years old;
- Cohort 1: Patients with suspected or confirmed myelofibrosis; Cohort 2: Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib.
- The expected survival time is over 3 months
- Voluntarily sign informed consent.
- Willing and able to follow the research protocol;
- The subject must be able to lie on the scanning bed for 20 minutes;
Exclusion
- Known allergic history to 68Ga FAPI or its excipients;
- Patients who can not tolerate intravenous drug administration (such as needle fainting and blood fainting history);
- Those who are not suitable for or unable to complete imaging tests such as PET due to special reasons, including claustrophobia and radiophobia;
- pregnant and lactating women;
- Workers who are exposed to radiation for a long period of time;
- Serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis/cirrhosis;
- Participating in other interventional clinical trials within 1 month before screening;
- Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy due to other cancers;
- There are other circumstances that the researcher thinks are not suitable for participating in this study;
Key Trial Info
Start Date :
November 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06151119
Start Date
November 22 2023
End Date
June 30 2027
Last Update
February 19 2025
Active Locations (1)
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1
Bing Xu
Xiamen, Fujian, China, 361000