Characterization of the benign lesions with increased 68Ga-FAPI-04 uptake in PET/CT.
Shan Zheng, Rong Lin, Shaoming Chen...
https://pubmed.ncbi.nlm.nih.gov/34424505/Actively Recruiting
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2026-07-21
500
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the usefulness of 68Ga-DOTANOTA-FAPI-04 positron emission tomographycomputed tomography PETCT for diagnosing primary and metastatic lesions across various cancer types. This early phase 1 interventional study aims to assess how well this imaging method detects tumors in patients with suspected, newly diagnosed, or previously treated malignant tumors. Participants receive a single intravenous injection of the 68Ga-DOTANOTA-FAPI-04 drug followed by a PETCT scan within a specified time frame. The study focuses on quantifying tumor uptake using the maximum standard uptake value SUVmax and calculates diagnostic measures such as sensitivity, specificity, positive and negative predictive values, and accuracy. During the study, participants undergo the PETCT scan after injection and provide informed consent. Researchers measure the standardized uptake value within 30 days and evaluate diagnostic efficacy. The study monitors outcomes related to tumor detection, and participation lasts around the time needed for these assessments, with no ongoing treatment or long-term follow-up specified.
CONDITIONS
68Ga-FAPI PET/CT in Patients With Various Types of Cancer
W
Weibing Miao, MD
S
Shan Zheng, MD
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First Affiliated Hospital of Fujian Medical University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single visit
Participants receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04 followed by a PET/CT scan for tumor detection.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Shan Zheng, Rong Lin, Shaoming Chen...
https://pubmed.ncbi.nlm.nih.gov/34424505/Shan Zheng, Junyu Lin, Youzhi Zhu...
https://pubmed.ncbi.nlm.nih.gov/36723892/Yun Chen, Shan Zheng, Jiaying Zhang...
https://pubmed.ncbi.nlm.nih.gov/35551610/First Affiliated Hospital of Fujian Medical University
Lead Sponsor