Radiotherapy Safety for Liver Malignancies Using Post-Treatment Imaging

A Retrospective Single-Center Study Utilizing AI-Based Radiomics on Pre- and Post-Radiotherapy CT Images to Explore the Safety Dose Threshold in Liver Malignancy Radiation Therapy

The goal of this retrospective observational study is to investigate the safety of radiation therapy for liver malignancies by analyzing data from patients who have already completed this treatment . The main questions it aims to answer are:

What is the specific radiation dose level that leads to a visible change on CT scans called a Focal Liver Reaction (FLR)? Why do some patients develop these imaging changes while others do not, based on their scan features and clinical information? Researchers will compare patients who developed FLR with those who did not to identify the factors associated with this reaction.

This study uses existing medical records and images; therefore, participants will not need to undergo any new interventions or procedures.

Study Overview

• Status: Completed
• Conditions: Liver Neoplasms; Radiation-Induced Liver Injury
• Intervention / Treatment: Other: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer

• Study Type: Observational
• Enrollment (Actual): 274

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • The Third Xiangya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with primary or metastatic liver malignancies who received liver radiotherapy (e.g., SBRT or IMRT) at the Third Xiangya Hospital of Central South University between July 2015 and September 2024 , and had complete dosimetric data and follow-up CT imaging available for retrospective analysis.

Description

Inclusion Criteria:

• Primary or secondary liver malignancies, including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), and secondary liver tumors.
• Liver function of Child-Pugh classification A or B.
• Completed EBRT treatment as planned.
• No other local treatment of liver lesions between EBRT and the follow-up imaging examination.
• Complete imaging re-examination data.
• Three-phase enhancement CT scans showing typical Focal Liver Reaction (FLR).
• The registration effect of follow-up CT and planning CT is satisfactory.

Exclusion Criteria:

• History of upper abdominal radiotherapy or liver transplantation.
• Failure to complete radiotherapy as scheduled.
• Previous cancer treatment-related toxicities that did not return to baseline or grade 0-1 (except for hair loss and peripheral neuropathy).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FLR Group; Patients who developed Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy	Other: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer; This is a retrospective observational study. The intervention (radiotherapy) was administered as part of standard clinical care prior to the study. Researchers are analyzing the outcomes of this previously delivered intervention.
Non-FLR Group; Patients who did not develop Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy	Other: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer; This is a retrospective observational study. The intervention (radiotherapy) was administered as part of standard clinical care prior to the study. Researchers are analyzing the outcomes of this previously delivered intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Threshold for Focal Liver Reaction (FLR)	The minimum radiation dose (in Gy) required to induce a radiologically visible Focal Liver Reaction (FLR) on follow-up CT imaging, as assessed by CT scan.	Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy
Predictors of FLR Susceptibility	Differences in radiomic features and clinical baseline characteristics (e.g., age, gender, liver function, and tumor size) between patients with radiologically confirmed Focal Liver Reaction (FLR) and those without, assessed by radiomic analysis and clinical data review.	Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy

Collaborators and Investigators

• Sponsor: Cao peiguo

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: CSU-2024-HCCRT001

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