Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287411
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-23
Brief Title:
Role of FAPI PETMR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies
Sponsor:
Xiao Chen
Organization:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study Overview
Official Title:
Role of FAPI PETMR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies
Status:
RECRUITING
Status Verified Date:
2024-03
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 study aimed to prospectively evaluate the utility of fibroblast activation protein inhibitor FAPI positron emission tomography PETmagnetic resonance MR combined with gadoxetate disodium in patients with clinical suspected hepatic malignancies lesion diameter 30cm with histopathological findings obtained from biopsy or resected surgical specimens or follow-up results as reference standards
Detailed Description:
1 Clinical and biological data including the course of disease underlying liver disease hepatitis or cirrhosis serum alpha-fetoprotein carcinoembryonic antigen and carbohydrate antigen 19-9 levels were collected from each patient
2 PET image analysis Each patient underwent both FAPI and fluorodeoxyglucose FDG PETMR including T1-weighted imaging T1WI T2-weighted imaging T2WI diffusion-weighted imaging DWI apparent diffusion coefficient ADC and gadoxetate disodium-enhanced MRI Record and evaluate the following indicators the maximum standardized uptake value SUVmax of lesions the target-to-background ratio TBR which was calculated by dividing the SUVmax of the lesion by the background SUVmean obtained from nontumor liver tissue
3 Pathological analysis Hematoxylin and eosin staining and immunohistochemical analyses will be performed Immunohistochemical analysis will be used to investigate the expression of glucose transporter-1 GLUT-1 and fibroblast activation protein FAP
2 PET image analysis Each patient underwent both FAPI and fluorodeoxyglucose FDG PETMR including T1-weighted imaging T1WI T2-weighted imaging T2WI diffusion-weighted imaging DWI apparent diffusion coefficient ADC and gadoxetate disodium-enhanced MRI Record and evaluate the following indicators the maximum standardized uptake value SUVmax of lesions the target-to-background ratio TBR which was calculated by dividing the SUVmax of the lesion by the background SUVmean obtained from nontumor liver tissue
3 Pathological analysis Hematoxylin and eosin staining and immunohistochemical analyses will be performed Immunohistochemical analysis will be used to investigate the expression of glucose transporter-1 GLUT-1 and fibroblast activation protein FAP
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