Evaluation of functional liver volume changes after stereotactic body radiation therapy based on hepatobiliary scan and its correlation with clinical toxicity, quality of life and biomarkers
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Percentage change in functional liver volume from baseline to three months post-SBRT using HIDA scan data.
研究概览
简要总结
This research aims to standardize Hepatobiliary Iminodiacetic Acid (HIDA) SPECT CT imaging parameters post-SBRT, ensuring consistent liver function assessment and enhancing clinical decision-making. By correlating HIDA scan results with dosimetric data and clinical toxicity, the study seeks to optimize SBRT protocols, reduce liver toxicity, and improve patient outcomes. It also aims to identify early predictors of toxicity through clinical and imaging biomarkers, enabling personalized treatment. Including an Indian patient population addresses data gaps, enhancing global applicability. The findings will support future multicenter trials, advancing liver function monitoring and post-SBRT management for better patient care.
The study aims to assess changes in functional liver volume three months after SBRT, using Hepatobiliary Scintigraphy (HBS) with a HIDA scan to evaluate liver function.
Eligible patients visiting the radiation oncology department will be recruited after informed consent. Baseline HIDA scans will be conducted before SBRT, either in the treatment planning position or without it.
SBRT will follow standard institutional protocols, including triphasic CT scans, contouring of Gross Tumor Volume (GTV) and Planning Target Volume (PTV), and adherence to SBRT dose constraints.
Patients will be monitored weekly during treatment, at 15 days post-SBRT, and every three months thereafter. Routine blood tests and a follow-up HIDA scan at three months will assess liver function changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 80 years.
- •Patients with a radiologically or histologically confirmed diagnosis of hepatocellular carcinoma (HCC).
- •Patients who provide written informed consent.
- •Patients classified as stages 0, A, B, or C according to the Barcelona Clinic Liver Cancer (BCLC) staging system.
- •Patients with Child-Pugh (CP) scores between A and B8, indicating adequate liver function.
- •Patients with adequate liver reserve, defined as liver volume minus gross tumor volume (GTV) more than 700 cc.
- •Patients with a platelet count morethan 50,000/µL.
排除标准
- •Patients with distant metastases.
- •Patients having a performance status of 3 or 4 according to the Eastern Cooperative Oncology Group (ECOG).
- •Patients who are unable or unwilling to provide informed consent.
结局指标
主要结局
Percentage change in functional liver volume from baseline to three months post-SBRT using HIDA scan data.
时间窗: HIDA scan done at baseline, 3months post SBRT(Stereotactic Body Radiotherapy)
Changes in the global liver function score (in %/min/m²) pre- and post-SBRT.
时间窗: HIDA scan done at baseline, 3months post SBRT(Stereotactic Body Radiotherapy)
Evaluate the absolute change in functional liver volume (in cc) as measured by HIDA scans at three months.
时间窗: HIDA scan done at baseline, 3months post SBRT(Stereotactic Body Radiotherapy)
次要结局
- Toxicity and Liver Function Monitoring – Assess toxicity incidence, Child-Pugh,Albumin and Bilirubin grade (ALBI), and Model for End Stage Liver Disease (MELD) score changes at 1, 3, 6, and 12 months post-SBRT.
研究者
Dr Shivacharan M
Kasturba Medical College, Manipal