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This project intends to apply XH06 PET/CT or PET/MR imaging to patients suspected or diagnosed with hepatocellular carcinoma (liver mass), and compare it with enhanced magnetic resonance imaging. Using surgical/biopsy pathology as the gold standard, the diagnostic efficacy of XH06 PET/CT or PET/MR imaging for primary and metastatic lesions of hepatocellular carcinoma will be evaluated. The purpose is to further confirm the advantages of XH06 PET/CT or PET/MR in the diagnosis and staging of hepatocellular carcinoma through prospective, multicenter clinical studies, to compensate for the shortcomings of conventional imaging techniques in the diagnosis and staging of hepatocellular carcinoma, and to provide more accurate information to guide clinical treatment decisions for hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET imaging targeting GPC3 in hepatocellular carcinoma | Experimental | Determine if targeting GPC3 PET is safe and effective method for imaging of hepatocellular carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-XH06 | Drug | For Cancer patients, subjects should have targeting GPC3 scans. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual and standardized uptake values assessment of lesions and biodistribution | At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting GPC3 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or higher stage. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological sections of tumour tissue | The excised tumour tissue was taken for immunohistochemistry to verify its GPC3 expression | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
1: Pregnant or lactating patients
2: The patient or their legal representative is unable or unwilling to sign the informed consent form
3: Acute systemic diseases and electrolyte imbalances
4: Patients known to be allergic to XH06 imaging agent or synthetic excipients
5: Individuals who are unable to complete PET/MR or PET/CT examinations (including inability to lie flat, claustrophobia, radiation phobia, etc.)
6: Researchers believe that those with poor compliance or other factors that are not suitable for participating in this trial
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Lan, PhD | Contact | 0086-027-83692633 | lxl730724@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan union hosptital | Wuhan | Hubei | 430022 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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