Imaging fibroblast activation protein in liver cancer: a single-center post hoc retrospective analysis to compare [68Ga]Ga-FAPI-04 PET/CT versus MRI and [18F]-FDG PET/CT.
Wei Guo, Yizhen Pang, Lanlin Yao...
https://pubmed.ncbi.nlm.nih.gov/33179149Actively Recruiting
Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID04416165
Comparison of FDG and FAPI PET/CT Scans in Patients With Various Types of Cancer
Led by The First Affiliated Hospital of Xiamen University · Updated on 2023-08-08
3000
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the use of 68Ga-DOTA-FAPI-04 PET/CT scans compared with 18F-FDG PET/CT scans to diagnose primary and metastatic tumors in patients with various types of cancer. The study aims to measure how well these imaging methods detect cancer lesions by comparing factors like sensitivity and specificity. This research is conducted by The First Affiliated Hospital of Xiamen University and focuses on adult patients with suspected or confirmed malignant tumors. Participants receive a single intravenous injection of both 18F-FDG and 68Ga-DOTA-FAPI-04 followed by PET/CT imaging within a set timeframe. These imaging tests are performed either for initial cancer assessment or to detect recurrence. The study measures tumor uptake using the maximum standard uptake value (SUVmax) to evaluate the diagnostic accuracy of each scan. During the study, participants undergo two PET/CT scans and provide informed consent. Researchers collect data on tumor detection accuracy, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy. The primary outcome is the SUV measured within 30 days, and secondary outcomes assess diagnostic effectiveness. The total participation spans about 30 days, during which safety and diagnostic results are monitored.
CONDITIONS
Brief Title
Comparison of FDG and FAPI in Patients With Various Types of Cancer
Who Can Participate
Age: 18Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Patients with suspected, newly diagnosed, or previously treated malignant tumors supported by MRI, CT, tumor markers, or pathology
- Patients scheduled for both 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT scans
- Patients able to provide informed consent and assent following ethical guidelines
You will not qualify if you...
- Patients with non-malignant lesions
- Pregnant patients
- Patients unable or unwilling to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Single day
Participants receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04 and undergo PET/CT imaging to assess tumor uptake and evaluate diagnostic efficacy.
1 visit (in-person)
Long-term Monitoring
Duration - 30 days
Participants are monitored for up to 30 days after imaging to evaluate diagnostic outcomes such as SUV and overall diagnostic efficacy.
Follow-up contact(s) as needed
Trial Site Locations
Total: 1 location
1
First affiliated hospital of xiamen university
Xiamen, Fujian, China, 0086-361000
Actively Recruiting
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Research Team
H
Hua Wu, PhD
H
Haojun Chen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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