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

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a special type of imaging called 68Ga-FAPI PET/CT to help diagnose and assess myelofibrosis, a condition that affects the bone marrow and can lead to serious health issues. The goal is to see how well this new imaging technique works compared to traditional CT scans, especially in figuring out the severity of the disease in patients.

To participate, you need to be at least 18 years old and either have suspected or confirmed myelofibrosis or have not been treated with a specific medication called ruxolitinib. You should also expect to live for more than three months and be able to lie still for about 20 minutes during the scan. However, if you have certain health conditions, are pregnant or breastfeeding, or have had recent treatments for other cancers, you may not be eligible. If you join the study, you’ll be helping researchers learn more about how to better diagnose and treat myelofibrosis for future patients.

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Eligibility criteria

• 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;