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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 18F-FDG PET/CT.
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 18F-FDG 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 18F-FDG PET/CT and GPC3-targeted PET/CT will be recorded by visual interpretation and compared. Imaging findings will be compared with pathological result and/or with contrast-enhanced MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GPC3-targeted PET/CT | Experimental | Each subject receives a single intravenous injection of GPC3-targeted probe and undergoes PET/CT imaging within the specified time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FDG PET/CT and GPC3-targeted PET/CT | Diagnostic Test | Participants will receive a single intravenous injection of 18F-FDG and 68Ga-GPC3, and undergo PET/CT imaging within the specified time. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic efficacy | The sensitivity, specificity, and accuracy of 18F-FDG PET/CT and GPC3-targeted PET/CT were calculated and compared to evaluate the diagnostic accuracy. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric SUVmax Stratified by Gastric Filling Status | 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Zhao | Contact | 86 18818350620 | wzhaoliang01@163.com | |
| Haojun Chen | Contact | 86 18659285282 | leochen0821@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| C537340 | Simpson-Golabi-Behmel syndrome |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |