Differentiating the Invasiveness of Lung Adenocarcinoma by Dual Energy CT Parameter

NCT06441357 | Recruiting

• 1 other identifier: TDFS20240328
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of Lung

Keywords

ECV, invasion, lung adenocarcinoma, DECT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acquire relative radiological features.

  2 years

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Cui Guangbin

  ang-Du Hospital

  STUDY CHAIR

Central Study Contacts

Cui Guangbin, Professor

CONTACT

18992898517; cgbtd@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 4, 2024
• Study Start: June 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-05

Locations

CN (1)