A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects must be ≥ 18 years of age at the time of signing informed consent
- •Diagnosis of primary liver malignancy (including hepatocellular carcinoma [HCC] or cholangiocarcinoma) or liver metastasis from any primary solid tumor site by characteristic imaging findings on CT or MRI, clinical presentation, and/or pathologic confirmation of diagnosis.
- •Subjects with other current or prior malignancies are eligible for this study.
- •Patients with liver metastases must have at least one of the following clinical factors that may affect liver function:
- •History of liver resection (at any time)
- •History of cirrhosis (any cause), fatty liver disease, or hepatic insufficiency due to any cause
- •Prior radiation to the upper abdomen including radioembolization
- •ECOG (Zubrod) Performance Status 0-
- •Subjects must have a Child-Turcotte-Pugh (CTP) score ≤ 7 to be eligible.
- •Patients who have been previously treated with non-SBRT liver directed therapies may be enrolled on study. At least 3 months must have elapsed between the most recent liver-directed therapy and study entry.
- •Ability to provide written informed consent and HIPAA authorization
- •Subjects with an allergy to contrast agents may be enrolled at the treating physician's discretion with appropriate pre-treatment and symptom management.
Exclusion Criteria
- •Subjects who are pregnant or planning to become pregnant during the study. Women of child bearing potential must have a negative pregnancy test
- •Subjects must not have received chemotherapy within 2 weeks of planned 1st day of RT.
- •No more than 3 lesions may be treated. The maximum sum of the diameter(s) of the lesion(s) must be ≤6 cm
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), active upper GI ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would in the opinion of the investigator limit compliance with study requirements
Arms & Interventions
Standard SBRT Planning
The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.
Theragnostic SBRT Planning
The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control.
Intervention: Hepatobiliary Iminodiacetic Acid (HIDA) scan (Diagnostic Test)
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)
- Duration of Local Control(Up to 15 months)
- Change in MELD Score(Up to 1 year)
- 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)
Investigators
Ryan Rhome,
Assistant Professor- Department of Radiation Oncology
Indiana University