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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Primary Myelofibrosis

Intervention / Treatment
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* Diagnostic Test: 68Ga FAPI PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| suspected or confirmed myelofibrosis<br>Patients with suspected or confirmed myelofibrosis; | Diagnostic Test: 68Ga FAPI PET/CT<br>* 68Ga FAPI PET/CT<br>|
| primary/secondary myelofibrosis<br>Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib. | Diagnostic Test: 68Ga FAPI PET/CT<br>* 68Ga FAPI PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis. | Up to 24 months | 
| Specificity | Specificity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis. | Up to 24 months | 
| Positive prediction rate | Positive prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis. | Up to 24 months | 
| Negative prediction rate | Negative prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis. | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myelofibrosis, positron emission tomography / computed tomography