A CT-based Radiomics Model To Predict Survival-graded Fibrosis In PDAC

Study Overview

A CT-based Radiomics Model to Predict Survival-graded Fibrosis in PDAC

Tumor fibrosis plays an important role in chemotherapy resistance in pancreatic ductal adenocarcinoma (PDAC), however there remains a contradiction in the prognostic value of fibrosis. We aimed to investigate the relationship between tumor fibrosis and survival in patients with PDAC, classify patients into high- and low-fibrosis groups, and develop and validate a CT-based radiomics model to non-invasively predict fibrosis before treatment.

This retrospective, bicentric study included 295 pretreated patients with PDAC. Tumor fibrosis was assessed using the collagen fraction (CF). Clinical-pathological variables were gathered, and radiological features were evaluated by three radiologists in consensus. The patients were followed up at 1, 3, 6, and 9 months postoperatively and every 3-6 months thereafter. All follow-up examinations included carbohydrate antigen 19-9 (CA 19-9) measurements and imaging (contrast-enhanced CT, contrast-enhanced MRI, ultrasonography, or positron emission tomography). The overall survival (OS) and disease-free survival (DFS) were also recorded. Cox regression analysis was used to evaluate the associations of CF with OS and DFS. Receiver operating characteristic (ROC) analyses were used to determine the rounded threshold of CF. An integrated model (IM) was developed by incorporating selected radiomic features and clinical-radiological characteristics. The predictive performance was validated in the test cohort (Center 2). It was hypothesized that tumor fibrosis could be classified into two survival-graded groups and that the incorporation of radiomics features and clinical-radiological features would help predict the status of fibrosis. Thus, the association between fibrosis and overall survival (OS)/disease-free survival (DFS) was determined, and the patients with PDAC were divided into high- and low-CF groups in this study. In addition, a CT-based radiomics model was developed and validated to non-invasively predict fibrosis before treatment in patients with PDAC from two centers. It was hypothesized that the performance of the integrated model would be superior to that of the clinical-radiological model.

Pancreatic Cancer

PROCEDURE: surgery

SYSUFAH2021025

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-02-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-02-13
First Submitted that Met QC Criteria 2024-02-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-02-20
First Posted (ACTUAL) 2024-02-20	Results First Posted N/A	Last Verified 2024-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: high fibrosis group No intervention had been adminstered during treatment of patients.	PROCEDURE: surgery Patients with suspected pancreatic cancer who underwent contrast-enhanced CT and pathological examinations after the surgery.
: low fibrosis group No intervention had been adminstered during treatment of patients.	PROCEDURE: surgery Patients with suspected pancreatic cancer who underwent contrast-enhanced CT and pathological examinations after the surgery.

Participant Group/Arm

Intervention/Treatment

: high fibrosis group

No intervention had been adminstered during treatment of patients.

PROCEDURE: surgery

Patients with suspected pancreatic cancer who underwent contrast-enhanced CT and pathological examinations after the surgery.

: low fibrosis group

No intervention had been adminstered during treatment of patients.

PROCEDURE: surgery

Patients with suspected pancreatic cancer who underwent contrast-enhanced CT and pathological examinations after the surgery.

Primary Outcome Measures	Measure Description	Time Frame
fibrosis	percentage	after the surgery

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients with suspected pancreatic tumors who underwent contrast-enhanced CT and pathological examinations at Center 1 and Center 2 were eligible for inclusion in this study.

(a) pathologically diagnosed PDAC by resection; (b) time intervals between contrast-enhanced CT and pathology less than 2 weeks; (c) no history of previous treatment such as resection, chemotherapy, or radiotherapy. The patients were excluded as follows: (a) unavailable pathological sections for evaluating the fibrosis; (b) incomplete clinical records; (c) missing CT images or poor CT image quality; (d) coincidence of other malignant tumors

Collaborators and Investigators

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Investigators

STUDY_DIRECTOR: Shi-Ting Feng, MD, First Affiliated Hospital, Sun Yat-Sen University

Publications

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