Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186427
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-12-15
Brief Title:
A Novel 68Ga Labeled FAP Ligand PETCT in Patients With Various Malignant Tumors
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Comparison of 68Ga-GPFAPI-04 and 18F-FDG PETCT in Patients With Malignant Tumors
Status:
RECRUITING
Status Verified Date:
2023-12
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:
68Ga-GPFAPI
Brief Summary:
The investigators designed and synthesized a novel fibroblast activation protein FAP ligand DOTA-GPFAPI-04 by assembling three functional moieties a quinoline-based FAP inhibitor for specifically targeting FAP a FAP substrate Gly-Pro as a linker for increasing the FAP protein interaction and a 2222-14710-tetraazacyclododecane-14710-tetrayltetraacetic acid DOTA chelator for radiolabeling with different radionuclides
Molecular docking studies investigated the FAP targeting ability of DOTA-GPFAPI-04 DOTA-GPFAPI-04 was then radiolabeled with 68Ga to give 68Ga-DOTA-GPFAPI-04 for positron emission tomography PET imaging The investigators found that the 68Ga-DOTA-GPFAPI-04 has high stability targeted specificity and longer retention time The tumor-to-muscle TM ratio for 68Ga-DOTA-GPFAPI-04 reached 915
Molecular docking studies investigated the FAP targeting ability of DOTA-GPFAPI-04 DOTA-GPFAPI-04 was then radiolabeled with 68Ga to give 68Ga-DOTA-GPFAPI-04 for positron emission tomography PET imaging The investigators found that the 68Ga-DOTA-GPFAPI-04 has high stability targeted specificity and longer retention time The tumor-to-muscle TM ratio for 68Ga-DOTA-GPFAPI-04 reached 915
Detailed Description:
At the beginning of 2022 the National Cancer Center released the latest statistical data showing that the incidence rate of malignant tumors in China reached 29391100000 and the mortality rate reached 17455100000 Malignant tumors have become an important public health issue affecting the health of Chinese residents bringing a heavy economic burden to the public health system Different from the cancer spectrum in developed countries digestive system tumors with poor prognosis in China such as lung cancer liver cancer stomach cancer intestinal cancer and esophageal cancer are at a high incidence while those with good prognosis in European and American developed countries are at a high incidence such as thyroid cancer breast cancer and prostate cancer Even the 5-year survival rate of thyroid cancer breast cancer and prostate cancer with good prognosis still lags behind that of developed countries such as the United States The main reason is the low number of early cases low early diagnosis rate and non-standard clinical diagnosis and treatment of late cases Therefore early detection diagnosis staging and intervention have become urgent issues to be addressed
Malignant tumors often have insidious onset and overlapping symptoms Most patients are discovered by chance and when clinical symptoms and signs are more obvious patients are often in the late clinical stage Relying solely on serum tumor markers for diagnosis may result in certain false positives and false negatives Imaging examination is the preferred and non-invasive evaluation method for malignant tumors with the advantages of being intuitive and simple Ultrasound imaging has the advantages of being non-invasive convenient and highly accurate in the diagnosis of superficial organs such as the thyroid breast and liver However the doctors experience greatly influences the detection results and the repeatability is poor Its application in staging efficacy evaluation and prognosis follow-up is limited CT and MR scans can provide detailed and accurate anatomical information for identifying the location of the primary lesion and local and distant metastases and are crucial for determining the optimal surgical plan and treatment selection However the accuracy of anatomical imaging is limited by the size and morphology of the lesion and small lesions are prone to misdiagnosis In addition some malignant tumor lesions have concealment making them difficult to detect and diagnose
The emergence of functional imaging devices has made real-time fusion of anatomical structures and functionalmetabolicbiochemical images possible Positron emission computed tomographyX-ray computed tomography PETCT uses specific molecular probes to target tumor visualization It can provide detailed information on the biochemical changes of tumor tissue at the cellular and molecular levels with better sensitivity and specificity than traditional imaging methods achieving the goal of accurate diagnosis 18F-FDG is currently the most widely used positron imaging agent in clinical practice with good sensitivity and specificity for lung cancer 18F-FDG is not a tumor-specific imaging agent and is susceptible to interference from patient eating and blood glucose levels Before the examination the patient needs to have an empty stomach for at least 6 hours and the blood sugar level needs to be lower than 110mmolL which is difficult for some diabetes patients to tolerate The physiological uptake of brain myocardium intestinal mucosa infected tissue or inflammatory cells can lead to high uptake of 18F-FDG resulting in a significant increase in false positive rates In addition some tumors such as well-differentiated hepatocellular carcinoma renal cell carcinoma and signet ring cell carcinoma have a low uptake rate of 18F-FDG and a high false negative rate Therefore developing new tumor-targeted molecular probes is very important
The latest research found that in tumor tissues especially epithelial tumors such as ovarian cancer gastric cancer lung cancer and breast cancer the tumor matrix fibroblast membrane highly expresses fibroblast activation protein FAP which is a type II transmembrane serine protease It is worth noting that the liver ovaries pancreas and stomach hardly exhibit FAP activity under normal conditions but after carcinogenesis the expression level of FAP is significantly increased Therefore based on the upregulation and selective expression of FAP after normal tissue carcinogenesis it has been identified as a potential biomarker for tumor-associated fibroblasts In recent years foreign scholars have achieved very good results in using positron-labeled FAP inhibitors to target FAP and display tumor stroma Although the studies were based on small sample data or case reports they achieved significantly better results than 18F-FDG Therefore further multi-case and head-to-head studies with 18F-FDG are necessary for various malignant tumors
Therefore this study used an intra-individual control to compare the head-to-head comparison between positron-labeled fibroblast activation protein inhibitors and 18F-FDG PETCT in detecting primary and metastatic lesions of malignant tumors
Malignant tumors often have insidious onset and overlapping symptoms Most patients are discovered by chance and when clinical symptoms and signs are more obvious patients are often in the late clinical stage Relying solely on serum tumor markers for diagnosis may result in certain false positives and false negatives Imaging examination is the preferred and non-invasive evaluation method for malignant tumors with the advantages of being intuitive and simple Ultrasound imaging has the advantages of being non-invasive convenient and highly accurate in the diagnosis of superficial organs such as the thyroid breast and liver However the doctors experience greatly influences the detection results and the repeatability is poor Its application in staging efficacy evaluation and prognosis follow-up is limited CT and MR scans can provide detailed and accurate anatomical information for identifying the location of the primary lesion and local and distant metastases and are crucial for determining the optimal surgical plan and treatment selection However the accuracy of anatomical imaging is limited by the size and morphology of the lesion and small lesions are prone to misdiagnosis In addition some malignant tumor lesions have concealment making them difficult to detect and diagnose
The emergence of functional imaging devices has made real-time fusion of anatomical structures and functionalmetabolicbiochemical images possible Positron emission computed tomographyX-ray computed tomography PETCT uses specific molecular probes to target tumor visualization It can provide detailed information on the biochemical changes of tumor tissue at the cellular and molecular levels with better sensitivity and specificity than traditional imaging methods achieving the goal of accurate diagnosis 18F-FDG is currently the most widely used positron imaging agent in clinical practice with good sensitivity and specificity for lung cancer 18F-FDG is not a tumor-specific imaging agent and is susceptible to interference from patient eating and blood glucose levels Before the examination the patient needs to have an empty stomach for at least 6 hours and the blood sugar level needs to be lower than 110mmolL which is difficult for some diabetes patients to tolerate The physiological uptake of brain myocardium intestinal mucosa infected tissue or inflammatory cells can lead to high uptake of 18F-FDG resulting in a significant increase in false positive rates In addition some tumors such as well-differentiated hepatocellular carcinoma renal cell carcinoma and signet ring cell carcinoma have a low uptake rate of 18F-FDG and a high false negative rate Therefore developing new tumor-targeted molecular probes is very important
The latest research found that in tumor tissues especially epithelial tumors such as ovarian cancer gastric cancer lung cancer and breast cancer the tumor matrix fibroblast membrane highly expresses fibroblast activation protein FAP which is a type II transmembrane serine protease It is worth noting that the liver ovaries pancreas and stomach hardly exhibit FAP activity under normal conditions but after carcinogenesis the expression level of FAP is significantly increased Therefore based on the upregulation and selective expression of FAP after normal tissue carcinogenesis it has been identified as a potential biomarker for tumor-associated fibroblasts In recent years foreign scholars have achieved very good results in using positron-labeled FAP inhibitors to target FAP and display tumor stroma Although the studies were based on small sample data or case reports they achieved significantly better results than 18F-FDG Therefore further multi-case and head-to-head studies with 18F-FDG are necessary for various malignant tumors
Therefore this study used an intra-individual control to compare the head-to-head comparison between positron-labeled fibroblast activation protein inhibitors and 18F-FDG PETCT in detecting primary and metastatic lesions of malignant tumors
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