Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06441357 |
Other study ID # |
TDFS20240328 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 1, 2024 |
Est. completion date |
June 30, 2026 |
Study information
Verified date |
May 2024 |
Source |
Tang-Du Hospital |
Contact |
Cui Guangbin, Professor |
Phone |
18992898517 |
Email |
cgbtd[@]126.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.