The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
Location status: Recruiting
Location contact
Haojun Chen
CONTACT
Liang Zhao
CONTACT
NCT Number: NCT07677774
The objective of the study is to evaluate the diagnostic value of GPC3-targeted PET/CT in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma, and to compare with contrast-enhanced MRI.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Xiamen, Fujian, 361000, China
Location status: Recruiting
Haojun Chen
CONTACT
Liang Zhao
CONTACT
This study is designed to investigate GPC3-targeted PET/CT as a noninvasive approach for detecting tumor lesions in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma. In this research, eligible patients will undergo contemporaneous GPC3-targeted PET/CT and contrast-enhanced liver MRI plus conventional extrahepatic imaging either for initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake will be quantified by the maximum standardized uptake value (SUVmax). Positive lesions detected by contrast-enhanced liver MRI + conventional imaging and GPC3-targeted PET/CT will be recorded by visual interpretation and compared. Imaging findings will be compared with pathological result and/or a composite reference standard incorporating radiologic follow-up, clinical course, and treatment response..
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single intravenous injection of 68Ga-GPC3, and undergo PET/CT imaging within the specified time.
Time frame: 1 year
The sensitivity, specificity, and accuracy of GPC3-targeted PET/CT and CE-MRI in detecting malignant hepatic lesions were calculated and compared.
Time frame: 1 year
The agreement of Barcelona Clinic Liver Cancer (BCLC) classification based on GPC3-targeted PET/CT with the reference BCLC classification will be assessed and compared with that based on conventional imaging, consisting of CE-MRI plus chest CT and other clinically indicated conventional imaging modalities.
Unit of Measure: Proportion of patients with correct BCLC classification (%)
Time frame: Within 14 days
In patients who undergo both examinations, the detection rates of reference-positive malignant lesions by GPC3-targeted PET/CT and 18F-FDG PET/CT will be calculated and compared, including hepatic lesions, metastatic lymph nodes, and distant metastases.
Unit of Measure: Lesion detection rate (%)
Time frame: 1 day
Gastric filling status will be assessed on the low-dose CT component of PET/CT imaging and categorized according to the degree of gastric distension. Tracer uptake in the stomach will be quantified using SUVmax and SUVmean.
Unit of Measure, SUVmax; SUVmean.
Contact information is provided by the study sponsor or research team.
Haojun Chen
CONTACT
Liang Zhao
CONTACT
The First Affiliated Hospital of Xiamen University
Other
Glypian-3 (GPC3)- Targeted PET Imaging in Hepatocellular Carcinoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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