Liver Cancer, AdultLiverINSPECTNCT02967848
Liver Function Investigation With SPECT
An observational study of Liver Cancer, Adult, run by Royal North Shore Hospital at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Liver Cancer, Adult
- What is being tested?
- 99mTc-mebrofenin hepatobiliary scintigraphy (HBS), Indocyanine Green and Liver Elasticity
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Oct 2016to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Liver Cancer patients attending the Northern Sydney Cancer Centre at the Royal North Shore Hospital
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
Official title: Liver Function Investigation With Single Photon Emission Computed Tomography After Radiotherapy
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.
Read the 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.
- Conditions
- Liver Cancer, Adult
- Being tested
- 99mTc-mebrofenin hepatobiliary scintigraphy (HBS), Indocyanine Green, Liver Elasticity
- Keywords
- Radiotherapy, Mebrofenin, Liver, Cancer, SPECT
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-mebrofenin hepatobiliary scintigraphy (HBS)Other
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 GreenOther
Also called ICG
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 ElasticityOther
Also called Liver FibroScan
This is an Ultrasound measurement of the elasticity of the liver.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 99mTc-mebrofenin hepatobiliary scintigraphy (HBS); Other: Indocyanine Green; Other: Liver Elasticity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
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
Measured: 3 years
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start19 Oct 2016
- Primary completionDec 2020
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Andrew Kneebone, Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967848
- Sponsor's protocol ID
- RESP/16/129
- Acronym
- LiverINSPECT
- Status last verified
- Feb 2026
- First submitted
- 16 Nov 2016
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be processed remotely at Peter MacCallum Cancer Centre, by the AI, Nicholas Hardcastle.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Function Investigation With Single Photon Emission Computed Tomography After Radiotherapy
- ClinicalTrials.gov ID
- NCT02967848
- Acronym / sponsor ID
- LiverINSPECT / RESP/16/129
- Conditions
- Liver Cancer, Adult
- Keywords
- Radiotherapy, Mebrofenin, Liver, Cancer, SPECT
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Study start
- 19 Oct 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Cancers in Liver | – | Other: 99mTc-mebrofenin hepatobiliary scintigraphy (HBS), Other: Indocyanine Green, Other: Liver ElasticityAdult 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Liver Cancer patients attending the Northern Sydney Cancer Centre at the Royal North Shore Hospital
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Patients with Cancers in Liver |
| Indocyanine GreenAlso: ICGICG 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 | Patients with Cancers in Liver |
| Liver ElasticityAlso: Liver FibroScanThis is an Ultrasound measurement of the elasticity of the liver. | Other | Patients with Cancers in Liver |
Primary outcome
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.
3 secondary outcomes
Correlation between 99mTC mebrofenin HBS and various measures of global function
Time frame: 3 years
Relationship between radiological features on CT images and SPECT images
Time frame: 2 years
Radiotherapy dose sparing of functional liver
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Yes. Data will be processed remotely at Peter MacCallum Cancer Centre, by the AI, Nicholas Hardcastle.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, Adult, run by Royal North Shore Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global and local liver function (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.