Tracking Liver Function Changes After Radiation Therapy: What Scans Reveal About Health and Recovery

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 - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082039

Enrollment

Registered

2025-03-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: C220- Liver cell carcinoma

Interventions

Intervention1: Hepatobiliary Iminodiacetic Acid(HIDA) Scan: HIDA scan performed at baseline and at 3 months after standard SBRT treatment to assess functional liver volume changes and correlate with c

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 80 years. 2. Patients with a radiologically or histologically confirmed diagnosis of hepatocellular carcinoma (HCC). 3. Patients who provide written informed consent. 4. Patients classified as stages 0, A, B, or C according to the Barcelona Clinic Liver Cancer (BCLC) staging system. 5. Patients with Child-Pugh (CP) scores between A and B8, indicating adequate liver function. 6. Patients with adequate liver reserve, defined as liver volume minus gross tumor volume (GTV) more than 700 cc. 7. Patients with a platelet count morethan 50,000/ L.

Exclusion criteria

Exclusion criteria: 1. Patients with distant metastases. 2. Patients having a performance status of 3 or 4 according to the Eastern Cooperative Oncology Group (ECOG). 3. Patients who are unable or unwilling to provide informed consent.

Design outcomes

Primary

Measure	Time frame
Percentage change in functional liver volume from baseline to three months post-SBRT using HIDA scan data. Changes in the global liver function score (in %/min/m ) pre- and post-SBRT. Evaluate the absolute change in functional liver volume (in cc) as measured by HIDA scans at three months.Timepoint: HIDA scan done at baseline, 3months post SBRT(Stereotactic Body Radiotherapy)	—

Secondary

Measure	Time frame
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. Liver Function and Dosimetry Correlation Evaluate HBS-based liver function changes and their relationship with dosimetric parameters and clinical toxicity. Quality of Life and Functional Impact Track global and physical liver function, HCC-specific Quality of Life (QoL), and their association with toxicity over time. Biomarkers and Predictive Modeling Analyze baseline biomarkers for toxicity risk and assess their predictive accuracy using ROC curves.Timepoint: Baseline assessments include pre-SBRT evaluations of liver function, QoL, toxicity scores, and biomarkers. HBS (Hepatobiliary Scintigraphy) is conducted pre-SBRT and at follow-up intervals (3, 6, 12 months). Toxicity, clinical scores (Child-Pugh, ALBI, MELD), and biomarkers are assessed at all follow-ups. QoL and liver function assessments align with 3, 6, and 12-month time points.	—

Measure

Time frame

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. Liver Function and Dosimetry Correlation Evaluate HBS-based liver function changes and their relationship with dosimetric parameters and clinical toxicity. Quality of Life and Functional Impact Track global and physical liver function, HCC-specific Quality of Life (QoL), and their association with toxicity over time. Biomarkers and Predictive Modeling Analyze baseline biomarkers for toxicity risk and assess their predictive accuracy using ROC curves.Timepoint: Baseline assessments include pre-SBRT evaluations of liver function, QoL, toxicity scores, and biomarkers. HBS (Hepatobiliary Scintigraphy) is conducted pre-SBRT and at follow-up intervals (3, 6, 12 months). Toxicity, clinical scores (Child-Pugh, ALBI, MELD), and biomarkers are assessed at all follow-ups. QoL and liver function assessments align with 3, 6, and 12-month time points.

—

Countries

India

Contacts

Public ContactDr Shivacharan M

Kasturba Medical College, Manipal

shirley.salins@manipal.edu9969557231

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026