Liver Function Investigation With Single Photon Emission Computed Tomography After Radiotherapy
概览
- 阶段
- 不适用
- 干预措施
- 99mTc-mebrofenin hepatobiliary scintigraphy (HBS)
- 疾病 / 适应症
- Liver Cancer, Adult
- 发起方
- Royal North Shore Hospital
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in global and local liver function
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
Professor Andrew Kneebone
Associate Professor Andrew Kneebone
Royal North Shore Hospital
入排标准
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: 99mTc-mebrofenin hepatobiliary scintigraphy (HBS)
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.
干预措施: Indocyanine Green
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.
干预措施: Liver Elasticity
结局指标
主要结局
Change in global and local liver function
时间窗: 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.
次要结局
- Correlation between 99mTC mebrofenin HBS and various measures of global function(3 years)
- Radiotherapy dose sparing of functional liver(2 years)
- Relationship between radiological features on CT images and SPECT images(2 years)