Radiotherapy Safety for Liver Malignancies Using Post-Treatment Imaging

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.

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Key information

Conditions

Liver Neoplasms Digestive System Diseases Digestive System Neoplasms Liver Diseases Neoplasms Neoplasms by Site Radiation-Induced Liver Injury

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third Xiangya Hospital

Changsha, Hunan, China

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer

Other

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.

Primary outcomes

Dose Threshold for Focal Liver Reaction (FLR)

Time frame: Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy

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.
Predictors of FLR Susceptibility

Time frame: Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy

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.

Sponsors and collaborators

Lead sponsor

Cao peiguo

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2025
Study completion: 2025
First posted: Jan 16, 2026
Registry last updated: Jan 16, 2026

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.

Completed