Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Radiation-Induced Liver Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- FLR Group
- description
- Patients who developed Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy
- interventionNames
- Other: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer
- label
- Non-FLR Group
- description
- Patients who did not develop Focal Liver Reaction (FLR) on follow-up CT imaging after radiotherapy
- interventionNames
- Other: Clinically Delivered Radiation Therapy (e.g., SBRT/IMRT) for Liver Cancer
Primary outcomes (2)
- measure
- Dose Threshold for Focal Liver Reaction (FLR)
- timeFrame
- Retrospectively, data collected from the beginning of radiotherapy to one year after the end of radiotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available