18 and older, any sex, with Liver Cancer or Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT PlanningPrimary· 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 p
Group
Value
95% CI
Theragnostic SBRT Planning
0.22
± 0.25
Standard SBRT Planning
0.02
± 0.07
Percentage of Participants for Whom Theragnostically Planned Radiation is Chosen for the Radiation Treatment PlanSecondary· Day -1 of Radiation Treatment
The percentage of participants for whom theragnostically planned radiation is chosen for the radiation treatment plan over the standard plan will be calculated along with the corresponding exact 95% Binomial confidence interval.
Group
Value
95% CI
Overall
64.3
39.2 – 89.4
Duration of Local ControlSecondary· Up to 15 months
Duration of local control was assessed by calculating the time from on study date to date of local failure. Patients who did not experience local failure were censored at their last evaluation date. Local failure (progressive disease at primary diagnosis site) was evaluated using RECIST v1.1 criteria:
Complete response: Disappearance of all target lesions; Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to
Group
Value
95% CI
Theragnostic SBRT Planning
NA
NA – NA
Standard SBRT Planning
NA
3.7 – NA
Progression Free SurvivalSecondary· Up to 15 months
Progression free survival was defined as the time from on study date to date of recurrence of any type or death from any cause. Patients who did not experience recurrence or death were censored at their last evaluation date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Group
Value
95% CI
Theragnostic SBRT Planning
NA
1.3 – NA
Standard SBRT Planning
NA
3.9 – NA
Overall SurvivalSecondary· Up to 3 years
Overall survival was defined as the time from on study date to death due to any cause. Patients who remained alive were censored at their last known alive date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Group
Value
95% CI
Theragnostic SBRT Planning
23.9
5.2 – 23.9
Standard SBRT Planning
27.5
1.4 – 27.5
Time to TransplantSecondary· Up to 15 months
Time to transplant was defined as the time from on study date to the date of transplant. Patients who did not receive transplant were censored at their off study date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Group
Value
95% CI
Theragnostic SBRT Planning
NA
NA – NA
Standard SBRT Planning
NA
NA – NA
Time to Distant Liver FailureSecondary· Up to 15 months
Time to distant liver failure was defined as the time from on study date to the date of distant liver failure. Patients who did not experience distant liver failure were censored at their date of last evaluation. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Group
Value
95% CI
Theragnostic SBRT Planning
NA
3.8 – NA
Standard SBRT Planning
NA
3.9 – NA
Time Until Salvage TreatmentSecondary· Up to 15 months
Time until salvage treatment was defined as the time from on study date to the start date of salvage treatment. Patients who did not receive salvage treatment were censored at their off study date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Group
Value
95% CI
Theragnostic SBRT Planning
NA
2.5 – NA
Standard SBRT Planning
NA
NA – NA
Number of Patients With Treatment-Related Adverse Events Grade 3 or AboveSecondary· Every 15 days for approximately 6 months
Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event with grade 3 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Group
Value
95% CI
Theragnostic SBRT Planning
0
Standard SBRT Planning
0
Change in MELD ScoreSecondary· Up to 1 year
Model for end-stage liver disease (MELD) score measures the severity of liver dysfunction. MELD scores range from 6 to 40 and are based on lab tests including serum creatinine, total bilirubin, and INR. The higher the number, the worse the liver function.
Baseline MELD Score
Group
Value
95% CI
Theragnostic SBRT Planning
8.8
± 1.9
Standard SBRT Planning
10.8
± 3.7
Change from Baseline to Mid-Treatment
Group
Value
95% CI
Theragnostic SBRT Planning
0.4
± 1.7
Standard SBRT Planning
-0.4
± 0.5
Change from Baseline to 1 Month
Group
Value
95% CI
Theragnostic SBRT Planning
0.2
± 1.2
Standard SBRT Planning
1.8
± 8.6
Change from Baseline to 3 Month
Group
Value
95% CI
Theragnostic SBRT Planning
0.8
± 3.9
Standard SBRT Planning
-2.0
± 2.8
Change from Baseline to 6 Month
Group
Value
95% CI
Theragnostic SBRT Planning
1.0
± 1.9
Standard SBRT Planning
-2.0
± 3.7
Change from Baseline 12 Month
Group
Value
95% CI
Theragnostic SBRT Planning
1.4
± 1.8
Standard SBRT Planning
-1.8
± 2.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 2 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 26 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03338062.