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

June 22, 2022 updated by: Wuhan Union Hospital, China

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with pulmonary nodules in the collaborating institutes.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Training dataset
No interventions
Diagnostic test: radiomics
The high-throughput extraction of large amounts of quantitative image features from medical images
External validation1
No interventions
Diagnostic test: radiomics
The high-throughput extraction of large amounts of quantitative image features from medical images
External validation2
No interventions
Diagnostic test: radiomics
The high-throughput extraction of large amounts of quantitative image features from medical images

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 24 hour before operation
Testing the sensitivity of Radiomics to predict STAS using the area under receiver operating characteristic curve
24 hour before operation
Specificity
Time Frame: 24 hour before operation
Testing the specificity of Radiomics to predict STAS using the area under receiver operating characteristic curve
24 hour before operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 12, 2023

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFSTAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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