Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
20 participants
OBSERVATIONAL
2016-10-19
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
100 Years
ALL
No
Sponsors
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Royal North Shore Hospital
OTHER
Responsible Party
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Professor Andrew Kneebone
Associate Professor Andrew Kneebone
Locations
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Royal North Shore Hospital
St Leonards, New South Wales, Australia
Countries
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Other Identifiers
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RESP/16/129
Identifier Type: -
Identifier Source: org_study_id
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