Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001499178
Ethics application status
Approved
Date submitted
1/10/2019
Date registered
30/10/2019
Date last updated
9/05/2022
Date data sharing statement initially provided
30/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Liver MaP - A Pilot Study of FDGal-PET and Dynamic MRI Evaluation of Regional Liver Function in Patients with Liver Cancer Undergoing Surgery or Stereotactic Radiation Therapy.
Scientific title
A Pilot Study of FDGal-PET and Dynamic MRI Evaluation of Regional Liver Function in Patients with Liver Cancer Undergoing Surgery or Stereotactic Radiation Therapy.
Secondary ID [1] 299457 0
Nil
Universal Trial Number (UTN)
U1111-1241-3319
Trial acronym
Liver MaP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with Liver Cancer 314667 0
Condition category
Condition code
Cancer 313002 313002 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315703 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321566 0
Regional Liver function as assessed by FDGa-PET/CT and DCE-MRI. This is a composite outcome
Timepoint [1] 321566 0
Four (4) weeks pre-treatment and post-treatment (3-7 days post surgery or 1 month post SBRT)
Secondary outcome [1] 375373 0
Survival scores as assessed by ALBI grade
Timepoint [1] 375373 0
Pre-treatment - 4 weeks prior to surgery or SBRT
Post treatment - 3-7 days post surgery or 1 month post SBRT, 3 months post treatment, 6 months post treatment, 12 months post treatment
Secondary outcome [2] 375374 0
Liver function as assessed by AST/ALT serum assay. This is a composite outcome
Timepoint [2] 375374 0
Pre-treatment - 4 weeks prior to surgery or SBRT
Post treatment - 3-7 days post surgery or 1 month post SBRT, 3 months post treatment, 6 months post treatment, 12 months post treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The dynamic enhancement curves will be extracted from the dynamic Gd-EOB-DTPA MRI and 18FD-Gal PET within each contoured liver subunit. The extracted curves are fitted using a novel model that has been developed to accurately model the physiology of the liver unlike existing approaches which underestimate the blood fraction.The new model accounts for the increased blood flow and rapid extraction of tracers within the liver. The presence of noise within dynamic images can also cause substantial numerical instability when fitting model parameters in addition to the need for motion correction of dynamic images. The HIRF and CSIRO team have addressed this issue using a novel numerical method that exploits the redundancy inherent to the data to ensure robustness and accuracy when fitting biological models with multiple parameters.
Dynamic analysis of MRI and PET images will be undertaken by the medical imaging department at PAH, CSIRO and HIRF. Correlation analysis between galactose metabolism (PET) and hepatobiliary function (MRI) will be performed at the scale of liver segments. The radiation dosimetry will be mapped to the pre- and post-treatment PET/MRI to determine quantitative dose-volume histograms correlating radiation dosimetry to post-treatment function.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/07/2021
Actual
30/07/2021
Date of last participant enrolment
Anticipated
2/01/2023
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
20
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14923 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 28192 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 303957 0
Hospital
Name [1] 303957 0
Metro South Hospital and health Services (Princess Alexandra Hospital)
Country [1] 303957 0
Australia
Primary sponsor type
Hospital
Name
Metro South Hospital and Health Services (Princess Alexandra Hospital)
Address
199 Ipswich Road
Woolloongabba
Queensand
4102
Country
Australia
Secondary sponsor category [1] 304124 0
None
Name [1] 304124 0
Address [1] 304124 0
Country [1] 304124 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304458 0
Metro South Hospital and Health Services HREC
Ethics committee address [1] 304458 0
Level 7, Translational Research Institute, 37 Kent Street, Woolloongabba QLD 4102
Ethics committee country [1] 304458 0
Australia
Date submitted for ethics approval [1] 304458 0
07/04/2020
Approval date [1] 304458 0
17/06/2020
Ethics approval number [1] 304458 0
MSH Governance Approval (RGO) 4/11/2020

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97014 0
A/Prof David Pryor
Address 97014 0
Radiation Oncology Ipswich Road
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba. Queensland
4102
Country 97014 0
Australia
Phone 97014 0
+61 07 3176 7853
Fax 97014 0
Email 97014 0
[email protected]
Contact person for public queries
Name 97015 0
David Pryor
Address 97015 0
Radiation Oncology Ipswich Road
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Queensland
4102
Country 97015 0
Australia
Phone 97015 0
+61 07 3176 7853
Fax 97015 0
Email 97015 0
[email protected]
Contact person for scientific queries
Name 97016 0
David Pryor
Address 97016 0
Radiation Oncology Ipswich Road
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Queensland
4102
Country 97016 0
Australia
Phone 97016 0
+61 07 3176 7853
Fax 97016 0
Email 97016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Information not available for sharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.