Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441357
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Brief Title:
Differentiating the Invasiveness of Lung Adenocarcinoma by Dual Energy CT Parameter
Sponsor:
Tang-Du Hospital
Organization:
Tang-Du Hospital
Study Overview
Official Title:
Differentiating the Invasiveness of Lung Adenocarcinoma by Dual Energy CT Using Extracellular Volume Measured in Delay Phase
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The core purpose of this study is to investigate whether the extracellular volume ECV fraction measured in delay phase by dual energy computed tomography DECT can distinguish precancerous lesions from early-stage lung adenocarcinomas which could assist clinical decision making for surgery operation indication and strategy
Detailed Description:
Although progression of lung adenocarcinoma LUAD depends on driver mutations it is also affected by tumor microenvironment TME including vessels immune cells and extracellular matrix ECM As major constituent of TME ECM mediates interactions between cancer cells and stromal cells promotes angiogenesis epithelial-mesenchymal transition causes metastasis and resistance to immune therapy Along with the progression of LUAD histologic stages from atypical adenomatous hyperplasia AAH and adenocarcinoma in situ AIS to minimally invasive adenocarcinoma MIA and finally to invasive adenocarcinoma IA the composition of the ECM changes a lot which has some characterizations same as interstitial pulmonary fibrosis Hence identifying the pathological ECM status may help differentiating the invasiveness of lung adenocarcinomas
Based on the theory that in delay phase the contrast medium is evenly distributed in the intravascular and extravascular-extracellular spaces and not entering the cell extracellular volume ECV fraction is considered as a potential quantitative imaging parameter for ECM It has been confirmed that ECV fraction is highly consistent with pathological fibrosis in cardiac and hepatic diseases In other lesions with fibrosis such as pancreatic and thymic epithelial tumors ECV fraction also has positive effects in malignancy prediction It has been verified that ECV fraction is capable of differentiating lung cancer with benign lung lesions and classifying lung cancers into three subtypes However there has yet no study testified it as an invasion predictor
The core purpose of this study is to investigate whether ECV fraction can distinguish precancerous lesions from early-stage lung adenocarcinomas and compare it with other confirmed radiological features in prediction performance which is clinically meaningful regarding optimal treatment selection and avoidance of unnecessary surgical procedures
Based on the theory that in delay phase the contrast medium is evenly distributed in the intravascular and extravascular-extracellular spaces and not entering the cell extracellular volume ECV fraction is considered as a potential quantitative imaging parameter for ECM It has been confirmed that ECV fraction is highly consistent with pathological fibrosis in cardiac and hepatic diseases In other lesions with fibrosis such as pancreatic and thymic epithelial tumors ECV fraction also has positive effects in malignancy prediction It has been verified that ECV fraction is capable of differentiating lung cancer with benign lung lesions and classifying lung cancers into three subtypes However there has yet no study testified it as an invasion predictor
The core purpose of this study is to investigate whether ECV fraction can distinguish precancerous lesions from early-stage lung adenocarcinomas and compare it with other confirmed radiological features in prediction performance which is clinically meaningful regarding optimal treatment selection and avoidance of unnecessary surgical procedures
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