Skip to main content
OpenTrials
Completed

NCT Number: NCT06908005

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).

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

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

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

Treatment and study plan

CT radiomic analysis

Other

Radiomic features of tumor tissue

Fibrosis assessment

Other

Fibrosis quantification was performed on picrosirius red (PSR)-stained tissue sections using color deconvolution and binarized collagen signal analysis in ImageJ software (v1.5)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 3, 2025
Registry last updated
Apr 8, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.