Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383520
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-22
Brief Title:
Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a diagnostic study Patients were recruited from patients with clinically suspected or confirmed hepatocellular carcinoma and healthy volunteers were recruited for PETor PETCT imaging targeting a GPC3-specific probe in the case of 68Ga-NOTA-aGPC3-scFv to observe the reaction of volunteers and patients after injection of drugs to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging and to perform PET CT imaging in patients with contraindications General Information clinical data blood routine liver and renal function and other imaging data were collected The final diagnosis was based on the histopathology of biopsy or surgical specimens
Detailed Description:
Liver cancer is one of the most common malignant tumors in the world and hepatocellular carcinoma HCC is the most prominent histopathological type Surgical resection and liver transplantation are the main radical methods for early HCC patients However due to its insidious onset more than 90 of HCC patients are already in local advanced stage or accompanied by distant metastasis when diagnosed so there is no surgical opportunity and the prognosis is very poor It is important to explore new methods and strategies for early and accurate diagnosis of HCC to improve the prognosis of patients
Traditional imaging methods such as multi-temporal computed tomography CT and magnetic resonance imaging MRI have been widely used in the diagnosis staging and treatment decision making of HCC but qualitative diagnosis cannot be achieved Nuclear medicine diagnostic tool 18F-Fluorodeoxyglucose positron emission tomographycomputed tomography 18F-FDG PETCT imaging technology has been widely used in the diagnosis of a variety of malignant tumors but due to its low diagnostic accuracy for HCC especially highly differentiated HCC its value in the early diagnosis of HCC is limited
GPC3 a member of the heparan sulfate glycoprotein family is composed of a core protein two heparan sulfate chains located at the C-terminal and phosphatidyl inositol anchors attached to the cell membrane Data analysis showed that GPC3 was significantly overexpressed in tumor cells of HCC patients but hardly expressed in normal liver tissue or in benign liver diseases making it the most specific tumor marker for HCC High expression of GPC3 is associated with poor prognosis in HCC patientssuggesting that GPC3 may be an important molecular target for accurate diagnosis and treatment of HCC
This project proposes to PET imaging targeting GPC3 in the diagnosis and staging of HCC and to compare the diagnostic efficacy with the pathology gold standard And this study was conducted to compensate for the lack of value of 18F-FDG PET imaging for the diagnosis and staging of malignant tumors by comparing PET imaging targeting GPC3 with the commonly used 18F-FDG PET imaging
Traditional imaging methods such as multi-temporal computed tomography CT and magnetic resonance imaging MRI have been widely used in the diagnosis staging and treatment decision making of HCC but qualitative diagnosis cannot be achieved Nuclear medicine diagnostic tool 18F-Fluorodeoxyglucose positron emission tomographycomputed tomography 18F-FDG PETCT imaging technology has been widely used in the diagnosis of a variety of malignant tumors but due to its low diagnostic accuracy for HCC especially highly differentiated HCC its value in the early diagnosis of HCC is limited
GPC3 a member of the heparan sulfate glycoprotein family is composed of a core protein two heparan sulfate chains located at the C-terminal and phosphatidyl inositol anchors attached to the cell membrane Data analysis showed that GPC3 was significantly overexpressed in tumor cells of HCC patients but hardly expressed in normal liver tissue or in benign liver diseases making it the most specific tumor marker for HCC High expression of GPC3 is associated with poor prognosis in HCC patientssuggesting that GPC3 may be an important molecular target for accurate diagnosis and treatment of HCC
This project proposes to PET imaging targeting GPC3 in the diagnosis and staging of HCC and to compare the diagnostic efficacy with the pathology gold standard And this study was conducted to compensate for the lack of value of 18F-FDG PET imaging for the diagnosis and staging of malignant tumors by comparing PET imaging targeting GPC3 with the commonly used 18F-FDG PET imaging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None