Using 68Ga-FAPI PET/CT imaging to diagnose and evaluate myelofibrosis.
A Study to Evaluate 68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.
This study is testing a new imaging method using 68Ga-FAPI PET/CT to see if it can better diagnose myelofibrosis compared to regular CT scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Drugs / interventions | ruxolitinib, chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT06151119 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic efficacy of 68Ga FAPI PET/CT imaging in patients with myelofibrosis, comparing its effectiveness to conventional CT imaging. The study will utilize bone marrow biopsy as the reference standard to evaluate key diagnostic metrics such as sensitivity, specificity, and predictive values. It will also focus on identifying different grades of fibrosis in affected patients. Participants will be monitored for their ability to tolerate the imaging procedure and will be required to provide informed consent.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspected or confirmed myelofibrosis.
Not a fit: Patients with known allergies to 68Ga FAPI or those unable to tolerate imaging procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing and grading myelofibrosis, leading to better patient management.
How similar studies have performed: While the use of PET/CT imaging in myelofibrosis is a relatively novel approach, similar imaging techniques have shown promise in other hematological conditions.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Xiamen, Fujian
- Bing Xu — Xiamen, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Bing Xu — The First Aiffiliated hosptical of xiamen University
- Study coordinator: Bing Xu
- Email: xubingzhangjian@126.com
- Phone: +8618750918842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.