The First Affiliated Hospital of Xiamen University
Phase
Observational
Started
2023-11-22
Last updated
2025-02-19
Condition(s) studied
Primary Myelofibrosis
Investigational drug(s) / intervention(s)
68Ga FAPI PET/CT
68Ga FAPI PET/CT: 68Ga FAPI PET/CT
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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;
Primary outcome measure(s)
Sensitivity — Up to 24 months Sensitivity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Specificity — Up to 24 months Specificity 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.
Negative prediction rate — Up to 24 months Negative prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Trial sites (1)
Facility
City
Region
Status
Bing Xu
Xiamen
Fujian
Recruiting
More The First Affiliated Hospital of Xiamen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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