Viewing Study NCT06614062



Ignite Creation Date: 2024-10-26 @ 3:41 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06614062
Status: COMPLETED
Last Update Posted: None
First Post: 2024-09-23

Brief Title: Clinical Study of 18F-FAPI-RGD in Ovarian Cancer
Sponsor: None
Organization: None

Study Overview

Official Title: Clinical Study of 18F Labeled Probe Targeting Fibroblast Activation Protein Inhibitor and Integrin Avβ3 FAPI-RGD in Ovarian Cancercomparison with 18F-FDG
Status: COMPLETED
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this observational study is to learn about the value of 18F-FAPI-RGD PETCT imaging in ovarian cancer Participants will undergo clinical evaluation and 18F-FAPI-RGD PETCT examination and compare it with 18F-FDG PETCT imaging
Detailed Description: Ovarian cancer is the malignant tumor with the highest mortality rate among women and also the most intractable gynecological malignant tumor in clinical treatment Its incidence rate and mortality are increasing year by year Chinas incidence rate of ovarian cancer ranks first in the worldDue to the lack of typical clinical symptoms and effective screening tools in the early stage more than 70 of patients were in advanced cancer when diagnosedthat is there was peritoneal andor distant metastasis The mortality rate was high mortalityincidence rate ratio was 60 the radical cure rate was low and the 5-year overall survival rate was only 30 The survival rate of ovarian cancer is closely related to staging stage I 5-year survival rate is 92 stage IV is 5 Therefore early and accurate detection and staging are of great significance for the selection of treatment methods and the improvement of patient survival ratePositron emission tomography PET is a non-invasive molecular imaging technique Currently 18F-FDG PETCT has been included as a routine examination in the postoperative evaluation of the NCCN ovarian cancer diagnosis and treatment guidelines as a supplementary examination method for preoperative evaluation Therefore 18F-FDG PETCT is recommended by NCCN as an imaging biomarker for ovarian cancer and performs well in early diagnosis treatment planning and postoperative evaluation However FDG PETCT also has some limitations such as its sensitivity being influenced by different histological subtypes such as ovarian mucinous carcinoma clear cell carcinoma or low-grade serous carcinoma In addition false negatives caused by physiological high uptake in the intestine and false positives caused by ovarian physiological uptake and some benign lesions such as cystadenoma endometrioma and acute inflammatory processes still exist Therefore a more effective imaging technique is needed to improve the detection and staging of ovarian tumors

α V β 3-Integrins play a crucial role in promoting and maintaining angiogenesis and have been identified as biomarkers of angiogenesis Research has found that integrins α V β 3 is highly expressed in neovascular endothelial cells and tumor cells including ovarian cancer and plays an important role in regulating tumor growth angiogenesis local invasion and metastasis potentialResearch has shown that 68 Ga-FAPI-04 is a novel radioligand targeting fibroblast activating protein FAP which has recently been used for tumor microenvironment imaging especially cancer associated fibroblasts CAFs with promising imaging results Research has shown that compared to 18F-FDG 68Ga-FAPI PETCT has higher sensitivity in detecting and diagnosing lymph node and peritoneal metastases in ovarian cancer

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None