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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07346573
Enrollment
274
Registered
2026-01-16
Start date
2019-05-01
Completion date
2025-03-01
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Neoplasms, Radiation-Induced Liver Injury

Brief summary

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.

Interventions

OTHERClinically 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.

Sponsors

Cao peiguo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Dose Threshold for Focal Liver Reaction (FLR)Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapyThe 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 SusceptibilityRetrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapyDifferences 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026