Radiomics-based Prediction Model of Tumor Spread Through Air Space in Lung Adenocarcinoma

September 3, 2021 updated by: Marco Anile, University of Roma La Sapienza

Could Radiomics Predict Tumor Spread Through Air Space in Lung Adenocarcinoma in All Computed Tomography Settings?

Spread through air space (STAS) has been reported as a negative prognostic factor in patients with lung cancer undergone sublobar resection. Its preoperative assessment could thus be useful to customize surgical treatment. Radiomics has been recently proposed to predict STAS in patients with lung adenocarcinoma. However, all the studies have strictly selected both imaging and patients, leading to results hardly applicable to daily clinical practice. The aim of this study is to test a radiomics-based prediction model of STAS in practice-based dataset and verify its validity and translational potentials.

Radiological and clinical data from 100 consecutive patients with resected lung adenocarcinoma were retrospectively collected for the training section. As in common clinical practice, preoperative CT images were acquired independently by different physicians and from different hospitals. Therefore, our dataset presents high variance in model and manufacture of scanner, acquisition and reconstruction protocol, endovenous contrast phase and pixel size. To test the effect of normalization in highly varying data, preoperative CT images and tumor region of interest were preprocessed with four different pipelines. Features were extracted using pyradiomics and selected considering both separation power and robustness within pipelines. After that, a radiomics-based prediction model of STAS were created using the most significant associated features. This model were than validated in a group of 50 patients prospectively enrolled as external validation group to test its efficacy in STAS prediction.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Roma, Italy, 00139
        • Dipartimento di chirurgia Generale e Specialistica "Paride Stefanini"

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing lung cancer surgery at Policlinico Umberto I Hospital, Rome

Description

Inclusion Criteria:

  • Patients with suspected or cito-histologically proven lung adenocarcinoma undergoing lung cancer surgery;
  • Available preoperative CT images
  • Age older than 18 years

Exclusion Criteria:

  • Chest wall infiltration
  • Induction radio or chemotherapy
  • Incomplete surgical resection

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

Cohorts and Interventions

Group / Cohort
Lung adenocarcinoma
Imaging from patients with surgically treated lung adenocarcinoma were collected and processed for the construction of the radiomics-based prediction model

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.

Investigators

  • Principal Investigator: Marco Anile, MD, La Sapienza Università di Roma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (ACTUAL)

February 1, 2020

Primary Completion (ACTUAL)

July 1, 2020

Study Completion (ACTUAL)

June 1, 2021

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (ACTUAL)

May 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Lung Adenocarcinoma

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