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

NCT06908005 | Completed DMC

• 1 other identifier: 2025-DZLC-02
• Study Type: observational
• Target: 508
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lung Cancer - Non Small Cell

Keywords

NSCLC; radiomics; PFS; fibrosis

Outcome Measures

Primary Outcomes (1)

• DFS (Disease-free survival)

  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 Outcomes (1)

• OS (overall survival）

  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.

Study Arms (2)

training set

Other: CT radiomic analysis; Other: Fibrosis assessment

external test set

Other: CT radiomic analysis; Other: Fibrosis assessment

Interventions

CT radiomic analysis OTHER

Radiomic features of tumor tissue

external test set; training set

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)

external test set; training set

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Jinling Hospital, China

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Fibrosis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 3, 2025
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)