Actively Recruiting
Preliminary Study on the Diagnostic Value of 18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors
Led by Hunan Cancer Hospital · Updated on 2024-08-16
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MR) for diagnosing primary and metastatic cancer lesions, detecting recurrence, and assessing pathological response across various cancer types. The study is observational and aims to assess how well these imaging methods perform compared to standard diagnosis using histopathology and follow-up. Participants with different types of cancer undergo imaging with 18F-FAPI-04 PET/CT and PET/MR scans. The tracer 18F-FAPI-04 is injected into patients before the scans. Tumor uptake is measured by maximum standard uptake value (SUVmax) and tumor to background ratio (TBR). The imaging results are compared using sensitivity, specificity, positive predictive value, negative predictive value, and accuracy to evaluate diagnostic performance. During the study, participants are assessed through these imaging procedures to monitor tumor presence, recurrence, or response to treatment. The primary outcome is the diagnostic performance evaluated over one year. The study includes participants aged 18 to 90 years and involves informed consent and ethical approval. The total duration and follow-up details are based on imaging and clinical evaluations to confirm findings.
CONDITIONS
Brief Title
18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with suspected, newly diagnosed, or previously treated malignant tumors supported by MRI, CT, tumor markers, or pathology report
- Ability to provide informed consent signed by participant, parent, or legal representative
- Assent given according to Clinical Research Ethics Committee guidelines
You will not qualify if you...
- Patients with non-malignant lesions
- Patients who are pregnant
- Inability or unwillingness to provide written informed consent by participant, parent, or legal representative
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 - 1 day
Participants undergo 18F-FAPI-04 injection followed by PET/CT and PET/MR imaging to assess malignant tumors.
1 visit (in-person)
Duration - 1 year
Participants are monitored for up to 1 year to evaluate diagnostic performance and clinical outcomes based on imaging results and follow-up.
Follow-up visits as per clinical care
Trial Site Locations
Total: 1 location
1
Hunan Cancer hospital
Changsha, Hunan, China, 410000
Actively Recruiting
Research Team
H
Hui Ye, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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