None listed
Conditions
Brief summary
The purpose of this study is to evaluate the "PRISM approach" where MRI imaging is used to improve radiation therapy treatment for liver cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, and have been diagnosed with liver cancer (either hepatocellular carcinoma or liver metastases). Study details All participants will undergo liver stereotactic body radiation therapy and MRI scans as standard of care. There will also be an additional MRI scan during SBRT, and liver function blood tests at three times: before, during, and 3 months after SBRT. Each MRI scan will take no longer than 1 hour and each blood test for liver function will take no more than 40 minutes. The results from these tests will be used to make maps of liver function, to optimise the delivery of radiation to the liver. It is hoped that this research can determine if the PRISM approach is feasible, and thus improve the effectiveness of liver cancer radiotherapy.
Interventions
All participants will undergo Liver SBRT as standard of care. Interventions include liver Magnetic Resonance Imaging (MRI) scans and Indocyanine Green (ICG) blood tests at three time-points - before, during and 3 months after SBRT.
All participants will undergo safety screening for liver MRI scans and ICG tests.
ICG tests - ICG tests will be performed prior to the MRI scan. ICG will be administered as a bolus dose injection of 0.5mg/kg through an intra-venous cannula inserted by a trained nur
All participants will undergo Liver SBRT as standard of care. Interventions include liver Magnetic Resonance Imaging (MRI) scans and Indocyanine Green (ICG) blood tests at three time-points - before, during and 3 months after SBRT. All participants will undergo safety screening for liver MRI scans and ICG tests. ICG tests - ICG tests will be performed prior to the MRI scan. ICG will be administered as a bolus dose injection of 0.5mg/kg through an intra-venous cannula inserted by a trained nurse. The ICG will be reconstituted with 5ml of water for every 25mg of ICG, leading to a dilution of 5mg ICG per 1ml. Serial transcutaneous ICG measurements will then be taken for 20 minutes using an ICG clearance meter using a finger clip device (LiMON, Pulsion, Germany). The device automatically calculates and displays ICG clearance rates from the serial measurements, which will be recorded on the participant’s electronic case report form (CRF). Participants will lie in the supine position and calibration will be performed before testing starts. Total time taken for ICG tests will be around 30-40 minutes. MRI scans - MRI scanning will be performed on a 3 Tesla MRI scanner by trained research radiographers as per the trial MRI Acquisition Guidelines. The MRI scan will include the injection of the standard clinical dose of MRI contrast agent Gadoxetate (Primovist, Bayer, Germany). The same intra-venous cannula, used for ICG testing, will be used for contrast agent injection, unless a new catheter is required. Primovist will be injected at the standard clinical dose of 0.1 mL/kg of patient body weight (equivalent to 0.025 mmol/kg). Patient body weight will be measured prior to each MRI scan. Injection will be performed by a power injector to obtain a constant injection rate and will be timed by the radiographer to occur just after the DCE-MRI acquisition is started. The MRI scan will be performed in the supine position and will take a maximum of one hour in total, including time for setup. The participant will be asked to remain still throughout the duration of the scan. SBRT treatment will remain standard of care and will not be affected by the MRI and ICG results. The MRI and ICG data will be used to create liver function based SBRT (PRISM) treatment plans for study purposes.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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)
Outcome results
None listed