Primary Myelofibrosis
Conditions
Keywords
Myelofibrosis, positron emission tomography / computed tomography
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.
Interventions
DIAGNOSTIC_TEST68Ga FAPI PET/CT
68Ga FAPI PET/CT
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactBing Xu
Backup ContactLong Liu
Outcome results
None listed