Personalised liver stereotactic body radiation therapy using magnetic resonance imaging for liver cancer

Not Applicable

• Conditions: hepatocellular carcinoma; liver metastases; Cancer - Liver

• Registration Number: ACTRN12622000371796
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-03
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Aged 18 years or older
•Clinically (diagnostic MRI) or histologically diagnosed with HCC or liver metastases
•Has provided written informed consent for participation in this trial
•ECOG performance status 0-2
•Life expectancy > 6 months
•HCC patients with liver cirrhosis must be Child-Pugh A or B7-8 within 6 weeks prior to study entry
•Suitable and consented for liver SBRT
•Unsuitable for RFA or resection or transplant
•Willing and able to undergo repeated MRI scans with Primovist and ICG tests
•Screened for MRI safety as per local policy
•Participants capable of childbearing are using adequate contraception and will do so throughout trial participation

Exclusion Criteria

•For HCC patients - Evidence of metastatic disease including nodal or distant metastases
•Cholangiocarcinoma
•Previous radiation to the liver (including SIRTEX)
•Has a known history of untreated HIV or active hepatitis B/C (no testing is required unless mandated by local health authority)
•Pregnant or lactating women
•On systemic therapy within 7 days before inclusion
•Contraindications to MRI
•Contraindications to ICG (participants will only be excluded from ICG tests, but can be eligible for the trial)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of MRI based SBRT planning - <br>The proportion of participants for whom the dose to gross tumour volume (GTV) in PRISM based plans is higher than the dose to GTV in conventional SBRT plans <br>a) with no mid-treatment adaptation of PRISM plans<br>b) with mid-treatment adaptation of PRISM plans<br><br>This outcome will be determined by comparison of the dose delivered to GTV in standard SBRT plans with the prescribed dose to GTV in PRISM plans. Standard of care SBRT plans will be obtained from the participant's medical treatment records.[At the end of the study]

Secondary Outcome Measures

Name	Time	Method
Change in spatial liver function, as obtained from the MRI, compared to pre-treatment timepoints[Measured at mid-treatment (after 3 fractions of SBRT if 5-fraction scheme or after 2 fractions if 3-fraction scheme) and 3 months post-treatment (after the end of SBRT treatment) timepoints]