Radiomics Combined With Frozen Section Prediction Model for Spread Through Air Space in Lung Adenocarcinoma

• Conditions: Lung Adenocarcinoma
• Interventions: Diagnostic Test: radiomics

• Registration Number: NCT05400304
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

a multifactorial model combining radiomics with frozen section analysis is a potential biomarker for assessing Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.

Detailed Description

Spread through air space (STAS) is a novel invasive pattern of lung adenocarcinoma and is also a risk factor for recurrence and worse prognosis of lung adenocarcinoma. Its preoperative assessment could thus be useful to customize surgical treatment. Radiomics and frozen section haave been recently proposed to predict STAS in patients with lung adenocarcinoma. Radiomics-based Prediction Model is highly sensitive but not specific for STAS detection. While, frozen section is highly specific but not sensitive for STAS detection in early lung adenocarcinomas.

Therefore, the proposed project aims to develop and validate a multifactorial model combining radiomics with frozen section analysis to assesse Spread Through Air Space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.

Study Timeline

• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Status Verified: 2022-06
• Study First Posted: 2022-06-01
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-29
• Study Start: 2022-07-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. intraoperative frozen section diagnosis and final pathology diagnosis are available
2. preoperative standard non-enhanced CT is available
3. Pathologically confirmed

Exclusion Criteria

1. with a previous history of radiation therapy, chemotherapy or biopsy
2. the time interval between the CT examination and surgery was more than two weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training dataset	radiomics	No interventions
External validation1	radiomics	No interventions
External validation2	radiomics	No interventions

Primary Outcome Measures

Name	Time	Method
Specificity	24 hour before operation	Testing the specificity of Radiomics to predict STAS using the area under receiver operating characteristic curve
Sensitivity	24 hour before operation	Testing the sensitivity of Radiomics to predict STAS using the area under receiver operating characteristic curve