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OpenTrials
Completed

NCT Number: NCT04893200

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dipartimento di chirurgia Generale e Specialistica "Paride Stefanini"

Roma, 00139, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensitivity

    Time frame: 24 hour before operation

    Testing the sensitivity of Radiomics to predict STAS using the area under receiver operating characteristic curve

  2. Specificity

    Time frame: 24 hour before operation

    Testing the specificity of Radiomics to predict STAS using the area under receiver operating characteristic curve

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 19, 2021
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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