LiverINSPECT: Liver Function Investigation With SPECT

Sponsor

Royal North Shore Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02967848

Collaborator

(none)

Enrollment

Location

37.4

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer, Adult	Other: 99mTc-mebrofenin hepatobiliary scintigraphy (HBS) Other: Indocyanine Green Other: Liver Elasticity

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Liver Function Investigation With Single Photon Emission Computed Tomography After Radiotherapy

Actual Study Start Date :

Oct 19, 2016

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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) 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: 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 Names: ICG Other: Liver Elasticity This is an Ultrasound measurement of the elasticity of the liver. Other Names: Liver FibroScan

Arm

Intervention/Treatment

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)

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: 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 Names:

ICG

Other: Liver Elasticity

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

Other Names:

Liver FibroScan

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

Correlation between 99mTC mebrofenin HBS and various measures of global function [3 years]
This correlation will be measured using liver elasticity, Indocyanine Green (ICG) and Child-Pugh and Model for End stage Liver Disease (MELD) scores
Relationship between radiological features on CT images and SPECT images [2 years]
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.
Radiotherapy dose sparing of functional liver [2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)