Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327386
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-17
Brief Title:
The Therapeutic Efficacy of 18F-FDG Combined With 18F-FAPI PETMR in Neoadjuvant Therapy for Gastric 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:
The Therapeutic Efficacy of 18F-FDG Combined With 18F-FAPI PETMR in Neoadjuvant Therapy for Gastric Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths Although surgical treatment can benefit the survival of the vast majority of patients currently only early gastric cancer patients can be cured directly through endoscopic resection or surgery alone Neoadjuvant therapy reduces tumor volume and improves tumor response rate through preoperative radiotherapy and chemotherapy thereby increasing R0 resection rate and improving overall survival without increasing postoperative complications and mortality Timely imaging re staging during neoadjuvant therapy can allow patients to enter the surgical stage earlier thereby reducing their preoperative burden According to the different stages of neoadjuvant therapy clinical staging can be divided into baseline stage cBSstage and clinical rest stage cReStage after neoadjuvant therapy
At present the conventional imaging methods for diagnosing cBStage in gastric cancer include CT endoscopic ultrasonography EUS and MRI The NCCN guidelines recommend CT for cBStage with a diagnostic accuracy of 771 to 889 Similarly EUS and MRI were also used for cBStage with accuracy rates of 650 to 921 and 714 to 826 respectively The application of diffusion-weighted imaging DWI has improved the accuracy of MRI diagnosis of cBStage to 93
However due to the destruction of the gastric wall structure by neoadjuvant therapy accurate imaging re staging is difficult Currently accurate tumor regression grading can only be obtained through surgical resection of pathological specimens For cReT after neoadjuvant therapy the diagnostic accuracy of EUS is only 63 T2 44 T3 68 T4 90 Due to the presence of chronic inflammatory reactions such as tumor cell apoptosis necrosis fibrosis etc in both the tumor and the critical normal gastric wall after neoadjuvant therapy imaging cannot accurately identify the level of gastric wall leading to the current low value of CT for cReT Meanwhile due to the fact that the pathological reactions of lymph nodes after neoadjuvant therapy are mainly subacute inflammatory reactions accompanied by scar tissue formation and not all lymph node volumes that experience these pathological reactions will rapidly decrease the accuracy of CT diagnosis of cReN is only 44 while the sensitivity and specificity of EUS diagnosis of cReN are 50 and 56 respectively
In addition positron emission tomography PET can reflect the abnormal metabolism protein synthesis DNA repair and cell proliferation of tumors at the molecular level providing important information in tumor grading diagnosis prognosis evaluation treatment decision-making and efficacy monitoring The conventional positron tracer 18F-FDG can reflect the glucose metabolism ability of different tissues while most types of malignant tumors exhibit high metabolism Therefore 18F-FDG can be used for the diagnosis staging and treatment monitoring of cancer However in gastric cancer patients 18F-FDG has certain limitations including 1 interference with physiological or inflammatory uptake of the gastric wall 2 Low uptake of 18F-FDG is present in signet ring cell carcinoma mucinous adenocarcinoma or other poorly differentiated cancers with high mucus content 3 There are cases of false positive FDG after immunotherapy In the study of SUV changes in the tumor area before and after treatment it was found that patients with postoperative pathological regression grades 1-5 Δ SUVs are between 0-70
Tumor associated fibroblasts are closely related to tumor growth invasion and distant metastasis and their activation requires the involvement of fibroblast activation protein FAP Therefore radiolabeled fibroblast activation protein inhibitor FAPI can achieve in vivo FAP targeted tracing and quantification by specifically binding to FAP Currently a large number of studies have shown that 18F-FAPI is superior to 18F-FDG in the staging and re staging of gastric cancer Furthermore prospective studies have shown a certain relationship between tumor regression grade TRG and 18F-FAPI rate of change parameters SUVmax SUVavg SUVR
Therefore in the early stage of this study 18F-FAPI combined with 18F-FDG PETMRI imaging was used to evaluate the efficacy of neoadjuvant therapy for gastric cancer preoperative assessment of tumor regression grade after treatment and re staging to guide the development of further clinical treatment plans
At present the conventional imaging methods for diagnosing cBStage in gastric cancer include CT endoscopic ultrasonography EUS and MRI The NCCN guidelines recommend CT for cBStage with a diagnostic accuracy of 771 to 889 Similarly EUS and MRI were also used for cBStage with accuracy rates of 650 to 921 and 714 to 826 respectively The application of diffusion-weighted imaging DWI has improved the accuracy of MRI diagnosis of cBStage to 93
However due to the destruction of the gastric wall structure by neoadjuvant therapy accurate imaging re staging is difficult Currently accurate tumor regression grading can only be obtained through surgical resection of pathological specimens For cReT after neoadjuvant therapy the diagnostic accuracy of EUS is only 63 T2 44 T3 68 T4 90 Due to the presence of chronic inflammatory reactions such as tumor cell apoptosis necrosis fibrosis etc in both the tumor and the critical normal gastric wall after neoadjuvant therapy imaging cannot accurately identify the level of gastric wall leading to the current low value of CT for cReT Meanwhile due to the fact that the pathological reactions of lymph nodes after neoadjuvant therapy are mainly subacute inflammatory reactions accompanied by scar tissue formation and not all lymph node volumes that experience these pathological reactions will rapidly decrease the accuracy of CT diagnosis of cReN is only 44 while the sensitivity and specificity of EUS diagnosis of cReN are 50 and 56 respectively
In addition positron emission tomography PET can reflect the abnormal metabolism protein synthesis DNA repair and cell proliferation of tumors at the molecular level providing important information in tumor grading diagnosis prognosis evaluation treatment decision-making and efficacy monitoring The conventional positron tracer 18F-FDG can reflect the glucose metabolism ability of different tissues while most types of malignant tumors exhibit high metabolism Therefore 18F-FDG can be used for the diagnosis staging and treatment monitoring of cancer However in gastric cancer patients 18F-FDG has certain limitations including 1 interference with physiological or inflammatory uptake of the gastric wall 2 Low uptake of 18F-FDG is present in signet ring cell carcinoma mucinous adenocarcinoma or other poorly differentiated cancers with high mucus content 3 There are cases of false positive FDG after immunotherapy In the study of SUV changes in the tumor area before and after treatment it was found that patients with postoperative pathological regression grades 1-5 Δ SUVs are between 0-70
Tumor associated fibroblasts are closely related to tumor growth invasion and distant metastasis and their activation requires the involvement of fibroblast activation protein FAP Therefore radiolabeled fibroblast activation protein inhibitor FAPI can achieve in vivo FAP targeted tracing and quantification by specifically binding to FAP Currently a large number of studies have shown that 18F-FAPI is superior to 18F-FDG in the staging and re staging of gastric cancer Furthermore prospective studies have shown a certain relationship between tumor regression grade TRG and 18F-FAPI rate of change parameters SUVmax SUVavg SUVR
Therefore in the early stage of this study 18F-FAPI combined with 18F-FDG PETMRI imaging was used to evaluate the efficacy of neoadjuvant therapy for gastric cancer preoperative assessment of tumor regression grade after treatment and re staging to guide the development of further clinical treatment plans
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 January 12026The detailed description is as follows
1 Patients A patient with primary gastric adenocarcinoma who underwent surgical resection after neoadjuvant treatment at the Army Specialized Medical Center from January 2024 to January 2026
2 Clinical data colection Record the course of disease laboratory tests tumor markers pre neoadjuvant MRI enhancement PETMR examination postoperative pathology and related immunohistochemistry of all patients
3 PETMR image analysis Record and evaluate the following indicatorsthe maximum mean standardized uptakevalue SUVmax SUVmean and standard uptake value ratio
4 Pathological analysis After collecting pathological specimens of the primary lesion and metastatic lymph nodes after surgery they were fixed with formalin solution and embedded in paraffin and three slices with a thickness of 4 were taken μ Slice of m The first slice was stained with HE The second slice was stained for glucose transporter 1 GLUT1 The third slice was stained with Fibroblast Activation Protein FAP And record the primary lesion regression grade TRG
5 Statiscal analysis 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 A patient with primary gastric adenocarcinoma who underwent surgical resection after neoadjuvant treatment at the Army Specialized Medical Center from January 2024 to January 2026
2 Clinical data colection Record the course of disease laboratory tests tumor markers pre neoadjuvant MRI enhancement PETMR examination postoperative pathology and related immunohistochemistry of all patients
3 PETMR image analysis Record and evaluate the following indicatorsthe maximum mean standardized uptakevalue SUVmax SUVmean and standard uptake value ratio
4 Pathological analysis After collecting pathological specimens of the primary lesion and metastatic lymph nodes after surgery they were fixed with formalin solution and embedded in paraffin and three slices with a thickness of 4 were taken μ Slice of m The first slice was stained with HE The second slice was stained for glucose transporter 1 GLUT1 The third slice was stained with Fibroblast Activation Protein FAP And record the primary lesion regression grade TRG
5 Statiscal analysis 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