Liver Function Investigation With SPECT

Liver Cancer, Adult Clinical Trial

— LiverINSPECT  

Official title:

Liver Function Investigation With Single Photon Emission Computed Tomography After Radiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02967848
• Other study ID #: RESP/16/129
• Status: Active, not recruiting
• Start date: October 19, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Royal North Shore Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patients with cancers of the liver who are not suitable for surgery or chemo/radio embolisation are often treated with stereotactic ablative body radiotherapy (SABR). SABR results in high local control rates but, similar to other treatment modalities, carries risk of damage to healthy surrounding liver. This study aims to use a novel nuclear medicine imaging tracer, 99mTcMebrofenin, to evaluate liver function before and after radiotherapy. Patients will have a 99mTcMebrofenin scan performed < 2 weeks before radiotherapy and 1 and 6 months after radiotherapy. At the same time points, indocyanine green (ICG) and liver elasticity tests will be performed. These are global measures of liver function, whereas 99mTcMebrofenin is both global and local. From the imaging data, the Investigators will be able to correlate change in local liver function in each sub volume of the liver with the radiotherapy dose it received. The Investigators will be able to thus measure the effect of radiotherapy on global and local liver function.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer, Adult

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital	St Leonards	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Royal North Shore Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	3 years
Secondary	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.	2 years
Secondary	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.	2 years