Clinical trial NCT02967848: Liver Function Investigation With SPECT
Official title: Liver Function Investigation With Single Photon Emission Computed Tomography After Radiotherapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Cancer, Adult
Keywords: Radiotherapy
Mebrofenin
Liver
Cancer
SPECT
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Liver Cancer patients attending the Northern Sydney Cancer Centre at the 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in global and local liver function
timeFrame: 3 years
Secondary outcomes:
measure: Correlation between 99mTC mebrofenin HBS and various measures of global function
timeFrame: 3 years
measure: Relationship between radiological features on CT images and SPECT images
timeFrame: 2 years
measure: Radiotherapy dose sparing of functional liver
timeFrame: 2 years
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
References: