| CTRI Number |
CTRI/2025/03/082039 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Observational] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tracking Liver Function Changes After Radiation Therapy: What Scans Reveal About Health and Recovery |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivacharan M |
| Designation |
PhD Research Scholar |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No 1, Department Of Radiation Oncology, Shirdi Sai Cancer Block, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9629590906 |
| Fax |
|
| Email |
shivacharan097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Lewis Salins |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No 1, Department Of Radiation Oncology, Shirdi Sai Cancer Block, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9969557231 |
| Fax |
|
| Email |
shirley.salins@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivacharan M |
| Designation |
PhD Research Scholar |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No 1, Department Of Radiation Oncology, Shirdi Sai Cancer Block, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9629590906 |
| Fax |
|
| Email |
shivacharan097@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital, Manipal, Udupi District, Karnataka state, India, 576104. |
|
|
Primary Sponsor
|
| Name |
Dr Shivacharan M |
| Address |
Room No 1,Department of Radiation Oncology, Shirdi Sai Cancer Block, Kasturba Medical College, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivacharan M |
Kasturba Hospital, Manipal |
Department of Radiation Oncology, Department of Nuclear Medicine
Udupi
KARNATAKA |
9629590906
shivacharan097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C220||Liver cell carcinoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Post Stereotactic Body radiation Therapy (SBRT) Hepatobiliary Iminodiacetic Acid (HIDA) scan. |
As an intervention, an HIDA scan performed 3 months after standard SBRT treatment to assess functional liver volume changes and correlate with clinical toxicity, biomarkers, and quality of life |
| Comparator Agent |
Pre Stereotactic Body radiation Therapy (SBRT) Hepatobiliary Iminodiacetic Acid (HIDA) scan. |
As a comparator, a pre-HIDA scan performed as a part of standard of care before SBRT treatment to assess baseline functional liver volume, clinical toxicity, biomarkers, and quality of life |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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/µL.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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/m²) pre- and post-SBRT.
Evaluate the absolute change in functional liver volume (in cc) as measured by HIDA scans at three months. |
HIDA scan done at baseline, 3months post SBRT(Stereotactic Body Radiotherapy) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
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. |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |