ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Regional Liver function as assessed by FDGa-PET/CT and DCE-MRI. This is a composite outcome

Timepoint [1]

Four (4) weeks pre-treatment and post-treatment (3-7 days post surgery or 1 month post SBRT)

Secondary outcome [1]

Survival scores as assessed by ALBI grade

Timepoint [1]

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]

Liver function as assessed by AST/ALT serum assay. This is a composite outcome

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Metro South Hospital and health Services (Princess Alexandra Hospital)

Address [1]

199 Ipswich Road
Woolloongabba Queensland
4102

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Hospital and Health Services HREC

Ethics committee address [1]

Level 7, Translational Research Institute, 37 Kent Street, Woolloongabba QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/04/2020

Approval date [1]

17/06/2020

Ethics approval number [1]

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

A/Prof David Pryor

Address

Radiation Oncology Ipswich Road
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba. Queensland
4102

Country

Australia

Phone

+61 07 3176 7853

Fax

david.pryor@health.qld.gov.au

Contact person for public queries

Name

David Pryor

Address

Radiation Oncology Ipswich Road
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Queensland
4102

Country

Australia

Phone

+61 07 3176 7853

Fax

david.pryor@health.qld.gov.au

Contact person for scientific queries

Name

David Pryor

Address

Radiation Oncology Ipswich Road
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Queensland
4102

Country

Australia

Phone

+61 07 3176 7853

Fax

david.pryor@health.qld.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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