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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02967848




Registration number
NCT02967848
Ethics application status
Date submitted
16/11/2016
Date registered
17/11/2016
Date last updated
5/03/2018

Titles & IDs
Public title
Liver Function Investigation With SPECT
Scientific title
Liver Function Investigation With Single Photon Emission Computed Tomography After Radiotherapy
Secondary ID [1] 0 0
RESP/16/129
Universal Trial Number (UTN)
Trial acronym
LiverINSPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Cancer, Adult 0 0
Condition category
Condition code
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - 99mTc-mebrofenin hepatobiliary scintigraphy (HBS)
Other interventions - Indocyanine Green
Other interventions - Liver Elasticity

Patients with Cancers in Liver - Adult patients with primary liver cancer or liver metastases from any other histology who will be measured before and after Radiotherapy by '99mTc-mebrofenin hepatobiliary scintigraphy (HBS), Indocyanine Green and Liver Elasticity.


Other interventions: 99mTc-mebrofenin hepatobiliary scintigraphy (HBS)
99mTc-mebrofenin HBS is a SPECT imaging procedure that allows evaluation of global and local liver function. Mebrofenin, bound to albumin, is taken up by hepatocytes in a similar manner to organic anions such as bilirubin. After hepatic uptake, the mebrofenin is excreted into the bile canaliculi. Dynamic imaging tools allow measurement of clearance rates for global function, and 3D SPECT imaging with corresponding CT allows visualisation of the local liver function with respect to anatomy. HBS allows direct visualisation of hepatocyte function.

Other interventions: Indocyanine Green
ICG is a fluorescent dye injected into the patient. The dye is exclusively excreted by the liver. The ICG clearance rate is measured in the finger of the subject.

Other interventions: Liver Elasticity
This is an Ultrasound measurement of the elasticity of the liver.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in global and local liver function - 99mTC-mebrofenin hepatobiliary scintigraphy images after stereotactic ablative body radiotherapy to cancers of the liver. This will be reported as a change in function as a function of delivered radiotherapy dose.
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Correlation between 99mTC mebrofenin HBS and various measures of global function - This correlation will be measured using liver elasticity, Indocyanine Green (ICG) and Child-Pugh and Model for End stage Liver Disease (MELD) scores
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Relationship between radiological features on CT images and SPECT images - Relationship between radiological features or changes visable on computed tomography (CT) image data and changes in local liver function as observed on 99mTC mebrofenin HBS.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Radiotherapy dose sparing of functional liver - The amount of sparing of dose to functional liver that can be achieved using 99mTC Mebrofenin HBS to guide treatment plan optimisation will be evaluated.
Timepoint [3] 0 0
2 years

Eligibility
Key inclusion criteria
- Aged 18 or older

- Has provided written Informed Consent for participation in this trial and is willing
to comply with the study

- Patients undergoing external beam radiotherapy at Northern Sydney Cancer Centre

- Histologically proven hepatocellular carcinoma or oligometastatic liver metastases (3
or less). Histological diagnosis will be obtained if clinically indicated.

- ECOG performance status 0-2
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous high-dose radiotherapy to the liver

- Previous SIRT

- Women who are pregnant or lactating

- Unwilling or unable to give informed consent

- No venous access

- Inability to lie supine and still for 30 minutes

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to indocyanine green, including those patients with a history of iodide or
seafood allergy (excluded from ICG testing only)

- Pacemaker (excluded from Fibroscan elasticity test only)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1 pilot study to assess feasibility and utility of 99mTc-mebrofenin
hepatobiliary scintigraphy for measurement of functional liver change due to radiotherapy.
Trial website
https://clinicaltrials.gov/show/NCT02967848
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clare Banks, M.P.H.
Address 0 0
Country 0 0
Phone 0 0
+61 2 9463 1345
Fax 0 0
Email 0 0
Clare.Banks@health.nsw.gov.au
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable