Liver Function Investigation With SPECT

Active, not recruiting

• Conditions: Liver Cancer, Adult
• Interventions: Other: 99mTc-mebrofenin hepatobiliary scintigraphy (HBS); Other: Indocyanine Green; Other: Liver Elasticity

• Registration Number: NCT02967848
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-10-19
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-18
• Primary Completion: 2020-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-21
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Cancers in Liver	99mTc-mebrofenin hepatobiliary scintigraphy (HBS)	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.
Patients with Cancers in Liver	Indocyanine Green	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.
Patients with Cancers in Liver	Liver Elasticity	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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.

Trial Locations

Locations (1)

Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia