Liver Function Investigation With SPECT

NCT02967848 | Active Not Recruiting

• 1 other identifier: RESP/16/129
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer, Adult

Keywords

Radiotherapy; Mebrofenin; Liver; Cancer; SPECT

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (3)

• Correlation between 99mTC mebrofenin HBS and various measures of global function

  3 years

• Relationship between radiological features on CT images and SPECT images

  2 years

• Radiotherapy dose sparing of functional liver

  2 years

Study Arms (1)

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: 99mTc-mebrofenin hepatobiliary scintigraphy (HBS); Other: Indocyanine Green; Other: Liver Elasticity

Interventions

99mTc-mebrofenin hepatobiliary scintigraphy (HBS) OTHER

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.

Patients with Cancers in Liver

Indocyanine Green OTHER

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.

Also known as: ICG

Patients with Cancers in Liver

Liver Elasticity OTHER

This is an Ultrasound measurement of the elasticity of the liver.

Also known as: Liver FibroScan

Patients with Cancers in Liver

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Liver Cancer patients attending the Northern Sydney Cancer Centre at the Royal North Shore Hospital

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Andrew Kneebone

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: October 19, 2016
• Primary Completion: December 1, 2020
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)