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Trial record 1 of 1 for:    NCT02967848
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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
Information provided by (Responsible Party):
Associate Professor Andrew Kneebone, Royal North Shore Hospital

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
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.

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Study Type : Observational
Estimated 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 : October 19, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Mebrofenin

Group/Cohort 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 Name: ICG

Other: Liver Elasticity
This is an Ultrasound measurement of the elasticity of the liver.
Other Name: Liver FibroScan

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Liver Cancer patients attending the Northern Sydney Cancer Centre at the Royal North Shore Hospital

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)

Information from the National Library of Medicine

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

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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

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Australia, New South Wales
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Contact: Clare Banks, MPH    +612 9463 1345    clare.banks@health.nsw.gov.au   
Contact: Carol Kwong, B.Nursing    +612 9463 1339    Carolyn.Kwong@health.nsw.gov.au   
Principal Investigator: Andrew Kneebone, MBBS         
Sponsors and Collaborators
Royal North Shore Hospital
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Responsible Party: Associate Professor Andrew Kneebone, Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT02967848    
Other Study ID Numbers: RESP/16/129
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be processed remotely at Peter MacCallum Cancer Centre, by the AI, Nicholas Hardcastle.
Keywords provided by Associate Professor Andrew Kneebone, Royal North Shore Hospital:
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Technetium Tc 99m mebrofenin
Molecular Mechanisms of Pharmacological Action