N/A
Completed N=15
A Pilot Study to Assess Theragnostically Planned Liver Radiation to Optimize Radiation Therapy
Source: ClinicalTrials.gov NCT03338062 ↗Enrolled (actual)
15
Serious AEs
28.6%
Results posted
Feb 2021
Primary outcomePrimary: Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning — 0.22; 0.02 %/min/m^2
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning |
0.22; 0.02 | — |
| SECONDARY Percentage of Participants for Whom Theragnostically Planned Radiation is Chosen for the Radiation Treatment Plan |
64.3 | — |
| SECONDARY Duration of Local Control |
NA; NA | — |
| SECONDARY Progression Free Survival |
NA; NA | — |
| SECONDARY Overall Survival |
23.9; 27.5 | — |
| SECONDARY Time to Transplant |
NA; NA | — |
| SECONDARY Time to Distant Liver Failure |
NA; NA | — |
| SECONDARY Time Until Salvage Treatment |
NA; NA | — |
| SECONDARY Number of Patients With Treatment-Related Adverse Events Grade 3 or Above |
0; 0 | — |
| SECONDARY Change in MELD Score |
8.8; 10.8; 0.4; -0.4; 0.2; 1.8 | — |
Eligibility Criteria
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 0-2.
- 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
Data sourced from ClinicalTrials.gov (NCT03338062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.