None listed
Conditions
Brief summary
The purpose of this study is to establish a predictive model of liver toxicity using a new MRI and PET scan protocol Who is it for? You may be eligible for this study if you are aged 18 or older and have a diagnosis of liver cancer. Your doctor may have recommended for you to undergo surgery or a special type of radiation therapy called Stereotactic Body Radiotherapy (SBRT). Study details If you consent to participate, you will be asked to undergo up to two additional scanning sessions involving PET and MRI scans. The first scanning session will be conducted in the weeks prior to your treatment. If your liver tumour is treated with SBRT the second scanning session will be conducted approximately one month following treatment. If your liver tumour is treated with surgery the second scanning session will be conducted in the week following your operation if it is feasible to do so and you have adequately recovered from surgery. You will be scanned on a PET/MR scanner which will simultaneously acquire PET and MRI images. You are required to fast for at least 4 hours prior to the scan, but you can drink water if required. The scanning sessions take approximately 30-60 minutes between 1 to 2 hours, and you will be in the molecular imaging department for 2-3 hours. Pictures are taken with you lying on the scanner bed with your arms above your head. The bed moves through the scanner which acquires pictures as the bed passes. After the test, you will remain slightly radioactive for the rest of the day, so we recommend that you avoid prolonged contact with children and pregnant women for about 6 hours after the start of the scan. Scanning sessions may be performed at the Princess Alexandra Hospital or the Herston Imaging Research Facility (HIRF), located on the Royal Brisbane and Women’s Hospital campus. As part of your usual care you will undergo an indocyanine green (ICG) test which provides the medical team with an estimate of your overall liver function to help them determine your best treatment. As part of this research project you may also be asked to undergo this test again following treatment prior to the second scanning session. All your medical treatment will be conducted as per usual according to the best possible standard of care as determined by your treating medical team It is hoped this research will lead to more accurate prediction of liver function after surgery or radiation therapy which could increase the proportion of patients appropriately selected for treatments, and reduce toxicity by protecting parts of the liver.
Interventions
1. Patients will undergo a 2-18 Fluoro-2-deoxy-D-galactose-Positron Emission Tomography – Computed Tomography (FDGal-PET/CT) and Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) imaging study and additional Indocyanine Green (ICG) measurements prior to and following either surgical resection or stereotactic body radiotherapy (SBRT).
a) Intervention: FDGalPET-CT and DCE-MRI and ICG treatment 4 weeks prior to treatment and following treatment (3-7 days post surgery OR 1 month post
1. Patients will undergo a 2-18 Fluoro-2-deoxy-D-galactose-Positron Emission Tomography – Computed Tomography (FDGal-PET/CT) and Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) imaging study and additional Indocyanine Green (ICG) measurements prior to and following either surgical resection or stereotactic body radiotherapy (SBRT). a) Intervention: FDGalPET-CT and DCE-MRI and ICG treatment 4 weeks prior to treatment and following treatment (3-7 days post surgery OR 1 month post SBRT) b) Scans completed by Medical Imaging department at either Princess Alexandra Hospital (PAH) or Royal Brisbane and Woman's Hospital (RBWH); blood tests conducted at PAH c) Frequency: - Surgical Arm: Scans: Within 4 weeks Prior to surgery, 3-7 days post-operatively; ICG prior to - SBRT Arm: Within 4 weeks Prior to SBRT, 1 month post SBRT Clinical Assessments and routine blood tests: Pre-treatment, Post treatment 3-7 days post surgery or 1 month post SBRT), 3 months, 6 months and 12 months post treatment. d) Location: either PAH or RBWH Medical Imaging department for scans; PAH for clinical Assessments e) clinical assessments as per above will assess outcomes 2. Indocyanine green (ICG) Test ICG testing takes 20-minutes and involves insertion of a small needle into the patient's arm and injection of a small volume of a chemical. Small amounts of blood (5ml) will be collected at 5 and 10-minute intervals. Levels of ICG in your blood will be measured by a finger probe. Imaging Procedures patient will be injected with 18FDGal as well as MRI Contrast prior to the scan.
Sponsors
Metro South Hospital and Health Services (Princess Alexandra Hospital)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Diagnosis of primary liver cancer • Aged 18 or older • ECOG performance status 0-2 • Diagnostic quality CT or MRI within 6 weeks of study entry. • Planned to undergo either surgical resection or SBRT • Prior liver directed or systemic therapies allowed. • Has provided written Informed Consent for participation in this trial and is willing to comply with the study requirements and follow-up.
Exclusion criteria
• Patient unable to undergo MRI (e.g. non compatible pacemakers) • Allergic reaction attributed to compounds of similar composition to ICG, including those patients with a history of iodine or seafood allergy. • Women who are pregnant or lactating • Unwilling or unable to give informed consent
Outcome results
None listed