RaFIST: A Radiomics-Based Tool for Intratumoral Fibrosis Stratification in Non-Small Cell Lung Cancer

April 6, 2025 updated by: Guangming Lu, Jinling Hospital, China

Development and Prognostic Validation of RaFIST: A Radiomics-Based Tool for Intratumoral Fibrosis Stratification in Non-Small Cell Lung Cancer

Patients with suspected Lung cancer who underwent contrast-enhanced CT and pathological examinations at Center 1 between January 2011 and January 2020 and Center 2 between September 2017 and Januray 2020 were eligible for inclusion in this study.The Clinical data, preoperative clinical information, laboratory results, CT images and pathological sections were collected. The investigators also collected the disease-free survival and overall survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and PyRadiomics was used to extract the radiomic features. Fibrosis quantification was performed on picrosirius red (PSR)-stained tissue sections using color deconvolution and binarized collagen signal analysis in ImageJ software. The investigators developed RaFIST, a radiomics-based stratification tool, to noninvasively quantify intratumoral fibrosis in non-small cell lung cancer (NSCLC) using contrast-enhanced CT imaging. And it was further tested on the held-out external test cohort. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

508

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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Jinling Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Jinling Hospital, China

Description

Inclusion Criteria:

  • Solid pulmonary nodule detected on CECT within 3 weeks pre-resection
  • No history of previous treatment such as chemotherapy, or radiotherapy

Exclusion Criteria:

  • Unavailable pathological sections
  • Missing CT images or hard-to-annotate CT images
  • Undergone anticancer therapy before CT
  • Loss to follow-up
  • Concurrent other malignant tumors

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
Intervention / Treatment
training set
Other: CT radiomic analysis
Radiomic features of tumor tissue
Other: Fibrosis assessment
Fibrosis quantification was performed on picrosirius red (PSR)-stained tissue sections using color deconvolution and binarized collagen signal analysis in ImageJ software (v1.5)
external test set
Other: CT radiomic analysis
Radiomic features of tumor tissue
Other: Fibrosis assessment
Fibrosis quantification was performed on picrosirius red (PSR)-stained tissue sections using color deconvolution and binarized collagen signal analysis in ImageJ software (v1.5)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS (Disease-free survival)
Time Frame: Record from the date of surgery to the date of recurrence or death from any cause, whichever comes first, and assess up to a maximum of 5 years.
DFS was defined as the duration from the date of primary surgery to the first occurrence of recurrence or death from any cause.
Record from the date of surgery to the date of recurrence or death from any cause, whichever comes first, and assess up to a maximum of 5 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
OS (overall survival）
Time Frame: Record from the date of surgery to the date of death from any cause，whichever comes first, and assess up to a maximum of 5 years.
Record from the date of surgery to the date of death from any cause，whichever comes first, and assess up to a maximum of 5 years.

Collaborators and Investigators

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

Sponsor

Jinling 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 (Actual)

April 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-DZLC-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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