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Clinical Trials in Australia / NCT02967848
Active, not recruiting Observational

Liver Function Investigation With SPECT

NCT02967848 · tracked via the Priya Life Science Australia tracker
Sponsor
Royal North Shore Hospital
Phase
Observational
Started
2016-10-19
Last updated
2026-02-05

Condition(s) studied

Liver Cancer, Adult

Investigational drug(s) / intervention(s)

99mTc-mebrofenin hepatobiliary scintigraphy (HBS)Indocyanine GreenLiver Elasticity

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.

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.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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 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)

Primary outcome measure(s)

  • Change in global and local liver function — 3 years
    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.

Trial sites (1)

FacilityCityRegionStatus
Royal North Shore Hospital St Leonards New South Wales

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02967848 on ClinicalTrials.gov ↗ ← All trials in Australia