Liver Function Investigation With SPECT (LiverINSPECT)
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|ClinicalTrials.gov Identifier: NCT02967848|
Recruitment Status : Unknown
Verified September 2019 by Associate Professor Andrew Kneebone, Royal North Shore Hospital.
Recruitment status was: Recruiting
First Posted : November 18, 2016
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment|
|Liver Cancer, Adult||Other: 99mTc-mebrofenin hepatobiliary scintigraphy (HBS) Other: Indocyanine Green Other: Liver Elasticity|
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 Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Liver Function Investigation With Single Photon Emission Computed Tomography After Radiotherapy|
|Actual Study Start Date :||October 19, 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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 Name: ICG
Other: Liver Elasticity
This is an Ultrasound measurement of the elasticity of the liver.
Other Name: Liver FibroScan
- Change in global and local liver function [ Time Frame: 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.
- Correlation between 99mTC mebrofenin HBS and various measures of global function [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967848
|Contact: Clare Banks, M.P.H.||+61 2 9463 1345 ext 31345||Clare.Banks@health.nsw.gov.au|
|Contact: Carol Kwong, R.N.||+61 2 9463 1399 ext 31339||Carolyn.Kwong@health.nsw.gov.au|
|Australia, New South Wales|
|Royal North Shore Hospital||Recruiting|
|St Leonards, New South Wales, Australia, 2065|
|Contact: Clare Banks, MPH +612 9463 1345 firstname.lastname@example.org|
|Contact: Carol Kwong, B.Nursing +612 9463 1339 Carolyn.Kwong@health.nsw.gov.au|
|Principal Investigator: Andrew Kneebone, MBBS|