Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284070
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-21
Brief Title:
Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer
Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Organization:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study Overview
Official Title:
Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Cancer associated fibroblasts CAFs can promote tumor cell proliferation migration invasion and angiogenesis through immunosuppressive effects and the production of mediators thereby promoting tumor growth and progression The characteristic of CAFs is high expression of fibroblast activation protein FAP In approximately 90 of epithelial derived tumors FAP is highly overexpressed on the membrane of CAFs Contrary to CAFs FAP expression is lower or absent in normal tissues Therefore FAP inhibitors FAPI targeting FAP can overcome the limitations of 18F-2-fluoro2-deoxy-D-glucose fluorodeoxyglucose18F-FDG PET imaging But like 18F-FDG wound healing fibrosis and inflammation can also uptake FAPI Therefore a comparison of the performance of 18F-FDG and 18F-FAPI PET imaging in diagnosing primary and metastatic lesions of various types of cancer is conducted to evaluate the potential value of these new radiopharmaceuticals as effective alternatives to 18F-FDG highlighting their advantages and limitations
Detailed Description:
This study is a prospective single study and has been approved by the ethics committee The subjects of this studywere from January 12024 to December 31 2029The detailed description is as follows
1 Patients The subjects we selected are adults who are not restricted by gender For details please refer to the Eligibility Criteria column
2 Clinical data collection Record the course of disease laboratory tests tumor markers inflammatory markers PET examinations and follow-up related imaging ultrasound CT or magnetic resonance imagingMRI information of all patients
3 CT or MRI image analysis Record the location and number of lesions measure the long diameter of the primary and metastatic lesions and the short diameter of lymph nodes on CT or MRI images
4 PET image analysis Record and evaluate the following indicators the maximum mean and peak standardized uptakevalue SUVmax SUVmean and SUVpeak Metabolic lesion volume MLV total lesion glycolysis TLG
5 Statistical analysis Use descriptive statistical methods to compare the age of patients and the standardized uptake values of FDG and FAPI Normal distribution data is represented as mean standard deviation while non normal distribution data is represented as median with IQR Compare the normal distribution data between two groups using paired two sample t-test and compare the non normal distribution data between two groups using McNemar test Using a four grid table McNemar χ Compare the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET through 2 tests calculate and compare the sensitivity specificity positive predictive value negative predictive value and accuracy of 18F-FDG and 18F-FAPI PET Due to the potential impact of tumor type on diagnosis subgroup analysis was conducted on the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET Due to the possibility of multiple metastatic lesions in a given participant the diagnostic results may be correlated within the participant Therefore sensitivity analysis of metastatic lesions is also performed based on a generalized linear mixed effects model by combining this correlation between different lesions within the same participant Double tailed P005 indicates a statistically significant difference
1 Patients The subjects we selected are adults who are not restricted by gender For details please refer to the Eligibility Criteria column
2 Clinical data collection Record the course of disease laboratory tests tumor markers inflammatory markers PET examinations and follow-up related imaging ultrasound CT or magnetic resonance imagingMRI information of all patients
3 CT or MRI image analysis Record the location and number of lesions measure the long diameter of the primary and metastatic lesions and the short diameter of lymph nodes on CT or MRI images
4 PET image analysis Record and evaluate the following indicators the maximum mean and peak standardized uptakevalue SUVmax SUVmean and SUVpeak Metabolic lesion volume MLV total lesion glycolysis TLG
5 Statistical analysis Use descriptive statistical methods to compare the age of patients and the standardized uptake values of FDG and FAPI Normal distribution data is represented as mean standard deviation while non normal distribution data is represented as median with IQR Compare the normal distribution data between two groups using paired two sample t-test and compare the non normal distribution data between two groups using McNemar test Using a four grid table McNemar χ Compare the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET through 2 tests calculate and compare the sensitivity specificity positive predictive value negative predictive value and accuracy of 18F-FDG and 18F-FAPI PET Due to the potential impact of tumor type on diagnosis subgroup analysis was conducted on the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET Due to the possibility of multiple metastatic lesions in a given participant the diagnostic results may be correlated within the participant Therefore sensitivity analysis of metastatic lesions is also performed based on a generalized linear mixed effects model by combining this correlation between different lesions within the same participant Double tailed P005 indicates a statistically significant difference
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