Actively Recruiting
A Study to Evaluate 68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-19
90
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic effectiveness of 68Ga FAPI PET/CT imaging for patients with myelofibrosis, a condition affecting the bone marrow. The study aims to compare this imaging technique with conventional CT scans and to identify different fibrosis grades using bone marrow biopsy as the reference standard. This observational study seeks to determine how well 68Ga FAPI PET/CT detects myelofibrosis by measuring sensitivity, specificity, and prediction rates. Participants include those with suspected or confirmed myelofibrosis and patients with primary or secondary myelofibrosis who have not been treated with ruxolitinib. The main intervention is the 68Ga FAPI PET/CT scan, which involves lying on a scanning bed for about 20 minutes. The study does not involve treatment but focuses on diagnostic imaging to assess the disease. During the study, participants will undergo the 68Ga FAPI PET/CT scan and bone marrow biopsy. Researchers will evaluate diagnostic accuracy by tracking sensitivity, specificity, positive prediction rate, and negative prediction rate over up to 24 months. Participants will be monitored for their ability to complete the imaging and adherence to study protocols, with safety considerations including excluding those with allergies or intolerance to the imaging agent and those with certain health conditions.
CONDITIONS
Brief Title
68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients with suspected or confirmed myelofibrosis
- Patients with primary or secondary myelofibrosis who have not been treated with ruxolitinib
- Expected survival time over 3 months
- Voluntarily signed informed consent
- Willing and able to follow the research protocol
- Able to lie on the scanning bed for 20 minutes
You will not qualify if you...
- Known allergy to 68Ga FAPI or its excipients
- Unable to tolerate intravenous drug administration (e.g., history of needle fainting)
- Unable or unsuitable to complete imaging tests like PET due to special reasons (e.g., claustrophobia, radiophobia)
- Pregnant or breastfeeding women
- Long-term radiation exposure workers
- Serious heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases, or hepatitis/cirrhosis
- Participating in other interventional clinical trials within 1 month before screening
- Receiving chemotherapy, immunotherapy, or molecular targeted therapy for other cancers
- Any other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo 68Ga FAPI PET/CT imaging and bone marrow biopsy to evaluate myelofibrosis diagnosis and fibrosis grading.
1 visit for 68Ga FAPI PET/CT imaging and biopsy
Duration - Up to 24 months
Participants are monitored for diagnostic outcomes including sensitivity, specificity, positive and negative prediction rates.
Follow-up assessments as scheduled up to 24 months
Trial Site Locations
Total: 1 location
1
Bing Xu
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
B
Bing Xu
L
Long Liu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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