Viewing Study NCT06304155



Ignite Creation Date: 2024-05-06 @ 8:14 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06304155
Status: RECRUITING
Last Update Posted: 2024-03-15
First Post: 2024-03-05

Brief Title: Application of FDG Combined With FAPI PET Dual Imaging in the Diagnosis and Staging of Oropharyngeal and Laryngeal 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 FDG Combined With FAPI PET Dual Imaging in the Diagnosis and Staging of Oropharyngeal and Laryngeal Cancer
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: According to statistics in 2020 new head and neck malignancies in the world accounted for 49 931931 cases of malignant tumors in the whole body and the new death cases were 467125 accounting for 47 of malignant tumors in the whole body The high incidence rate and mortality brought great burden to the medical system In addition due to various types of head and neck cancer hidden location impact on function and quality of life and low overall survival rate this type of disease has seriously threatened human health and social development The incidence of oropharyngeal cancer and laryngeal cancer is more subtle Traditional examination methods include CTcomputer tomography MRmagnetic resonance and laryngoscopy but they cannot make accurate judgments on the systemic TNMprimary tumor regional nodes metastasis staging of oropharyngeal cancer and laryngeal cancer 18F-FDG18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose PETCT examination can better diagnose and stage compared to traditional examination methods However due to the interference of more inflammatory lesions or physiological uptake in the pharynx the false positive rate of 18F-FDG PETCT examination is significantly increased 18F-FAPI18F-fibroblast activation protein inhibitors is a novel broad-spectrum tumor imaging agent that can be specifically uptake by fibroblasts in the tumor microenvironment and has lower physiological uptake and acute inflammatory lesion uptake in the larynx 18F-FAPI PETCT examination can more accurately stage tumors throughout the body than 18F-FDG PETCT examination Combined with PETMR local scanning it will further improve the accuracy of T and N staging of local tumors Therefore It is of great significance for clinical diagnosis and treatment to effectively and reliably determine the systemic TNM staging of oropharyngeal and laryngeal cancer through non-invasive methods
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 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 CT examination MR examination laryngoscopy examination PETCT examination PETMR examination and other 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