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CompletedNCT04893200Updated Sep 5, 2021

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

An observational study in Lung Adenocarcinoma, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-05.

Sponsored by University of Roma La Sapienza · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lung Adenocarcinoma

Keywords

  • Spread Through Air Space; Radiomics
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 150 is close to the median of 153 across 332 observational studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • Chest wall infiltration
  • Induction radio or chemotherapy
  • Incomplete surgical resection
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • Lung adenocarcinoma

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

06

What researchers measure

Primary outcomes

  1. Sensitivity

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

    Time frame: 24 hour before operation

  2. Specificity

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

    Time frame: 24 hour before operation

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Study locations

1 site
  • Dipartimento di chirurgia Generale e Specialistica "Paride Stefanini"
    Roma, 00139, Italy
08

References and documents

Publications

  • Jiang C, Luo Y, Yuan J, You S, Chen Z, Wu M, Wang G, Gong J. CT-based radiomics and machine learning to predict spread through air space in lung adenocarcinoma. Eur Radiol. 2020 Jul;30(7):4050-4057. doi: 10.1007/s00330-020-06694-z. Epub 2020 Feb 28. PubMed 32112116 ↗
  • Chen D, She Y, Wang T, Xie H, Li J, Jiang G, Chen Y, Zhang L, Xie D, Chen C. Radiomics-based prediction for tumour spread through air spaces in stage I lung adenocarcinoma using machine learning. Eur J Cardiothorac Surg. 2020 Jul 1;58(1):51-58. doi: 10.1093/ejcts/ezaa011. PubMed 32011674 ↗
  • Zhuo Y, Feng M, Yang S, Zhou L, Ge D, Lu S, Liu L, Shan F, Zhang Z. Radiomics nomograms of tumors and peritumoral regions for the preoperative prediction of spread through air spaces in lung adenocarcinoma. Transl Oncol. 2020 Oct;13(10):100820. doi: 10.1016/j.tranon.2020.100820. Epub 2020 Jul 1. PubMed 32622312 ↗
  • Bassi M, Russomando A, Vannucci J, Ciardiello A, Dolciami M, Ricci P, Pernazza A, D'Amati G, Mancini Terracciano C, Faccini R, Mantovani S, Venuta F, Voena C, Anile M. Role of radiomics in predicting lung cancer spread through air spaces in a heterogeneous dataset. Transl Lung Cancer Res. 2022 Apr;11(4):560-571. doi: 10.21037/tlcr-21-895. PubMed 35529792 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04893200
Lead sponsor
University of Roma La Sapienza
Responsible party
Marco Anile (Principal Investigator, University of Roma La Sapienza) — Principal investigator
First posted
May 19, 2021
Start date
Feb 1, 2020
Primary completion
Jul 1, 2020
Completion
Jun 1, 2021
Last update
Sep 5, 2021

Study contacts

Marco Anile, MD
principal investigator · La Sapienza Università di Roma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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