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

Lung Adenocarcinoma Clinical Trial

Official title:

Preoperative CT-based Radiomics Combined With Intraoperative Frozen Section is Predictive of Spread Through Air Space in Early Lung Adenocarcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05400304
• Other study ID #: RFSTAS
• Status: Not yet recruiting
• Start date: July 1, 2022
• Est. completion date: May 12, 2023

Study information

• Verified date: June 2022
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: May 12, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma

Intervention

Diagnostic Test:
• radiomics
The high-throughput extraction of large amounts of quantitative image features from medical images

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Testing the sensitivity of Radiomics to predict STAS using the area under receiver operating characteristic curve	24 hour before operation
Primary	Specificity	Testing the specificity of Radiomics to predict STAS using the area under receiver operating characteristic curve	24 hour before operation