A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Cancer
- Sponsor
- Indiana University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment planning. The other treatment plan will be created using routine procedures with the addition of two imaging scans; a HIDA (Hepatobiliary Iminodiacetic Acid) scan and an MRI (Magnetic Resonance Imaging) scan. This study will evaluate if adding these imaging scans to treatment planning can reduce the amount of radiation to healthy liver tissue during treatment.
Investigators
Ryan Rhome,
Assistant Professor- Department of Radiation Oncology
Indiana University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning
Time Frame: Day -1 of Radiation Treatment
The functional reserve of the liver for both standard SBRT planning and theragnostic SBRT planning will be calculated for each patient regardless of which plan was ultimately chosen. Function reserve of the liver = (number of counts outside 15 Gy isodose line / total number of counts within the liver) \* global liver function; where global liver function is the rate of liver uptake (%/min) between 150 to 300 seconds normalized to body surface area (m\^2) using the Du Bois method. The difference in functional reserve between the theragnostic plan and the standard plan was calculated for each patient.
Secondary Outcomes
- Time Until Salvage Treatment(Up to 15 months)
- Overall Survival(Up to 3 years)
- Percentage of Participants for Whom Theragnostically Planned Radiation is Chosen for the Radiation Treatment Plan(Day -1 of Radiation Treatment)
- Progression Free Survival(Up to 15 months)
- Change in MELD Score(Up to 1 year)
- Duration of Local Control(Up to 15 months)
- Time to Transplant(Up to 15 months)
- Time to Distant Liver Failure(Up to 15 months)
- Number of Patients With Treatment-Related Adverse Events Grade 3 or Above(Every 15 days for approximately 6 months)