Differentiating the Invasiveness of Lung Adenocarcinoma by Dual Energy CT Parameter

Differentiating the Invasiveness of Lung Adenocarcinoma by Dual Energy CT Using Extracellular Volume Measured in Delay Phase

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.

Study Overview

• Status: Recruiting
• Conditions: Adenocarcinoma of Lung

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Cui Guangbin, Professor; Phone Number: 18992898517; Email: cgbtd@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Recruiting
      • Tangdu Hospital
      • Contact: Cui Guangbin, Professor; Phone Number: 18992898517; Email: cgbtd@126.com
      • Contact: Jiang Nan; Phone Number: 18093701139; Email: tdfs_jn@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary nodules who intend to have contrast enhanced CT in Tangdu hospital.

Description

Inclusion Criteria:

• patients older than 18 years old with pulmonary nodules (diameter≤3 cm).
• pathologically confirmed as lung adenocarcinoma.
• without history of other malignancies.
• accurate hematocrit within 1 week before contrast enhanced dual energy CT examination.

Exclusion Criteria:

• with a history of allergy to iodine contrast agents and other reasons who are unable to complete the examination.
• without histopathology of invasion stage, such as AAH, AIS, MIA and IAC.
• history of chemotherapy, radiotherapy, or other anti-tumor therapy before contrast enhanced dual energy CT.
• poor image quality.
• contrast enhanced dual energy CT scans ≥ 4 weeks before surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with preinvasive lung adenocarcinomas; preinvasive lung adenocarcinomas include atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA)
Patients with invasive lung adenocarcinomas; invasive adenocarcinoma(IAC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acquire DECT parameters in patients with pulmonary nodules.	Including iodine concentration (IC) in delay phase, normalized IC (NIC), effective atomic number (Zeff), and CT attenuation values of nodules from virtual monochromatic images (VMIs) (energy range from 40 to 150 keV, 10keV as interval).	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acquire relative radiological features.	Including consolidation tumor ratio (CTR), nodule's maximum diameter, spiculation, lobulation, fibrosis, distortion or cut-off of vessels and bronchi.	2 years

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Investigators: Study Chair: Cui Guangbin, ang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Estimated): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ECV, invasion, lung adenocarcinoma, DECT
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: TDFS20240328

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No