Functional Liver After SBRT

Официальное название

Changes in Functional Liver Tissue After Liver Metastasis Irradiation: Pilot Study of Functional Imaging Before and After Stereotactic Body Radiotherapy

Обзор

In this study, the investigators aim to determine the dose-effect relationship between radiation dose and liver function by performing a hepatobiliary scintigraphy (HEBIS) before and after stereotactic body radiotherapy (SBRT) for patients with liver metastases. HEBIS is a nuclear imaging technique to quantitatively assess liver function. It better predicts the risk of postsurgical liver failure compared to volumetry alone. To prevent liver failure after SBRT, current clinical dose constraints require that ≥ 700 ml of normal liver should receive less than 15 Gy in 3 fractions. The exact local dose-effect relation is however unknown. Doses below 15 Gy are still damaging, while liver tissue receiving doses above 15 Gy will retain some function. By associating the 3D radiation dose distribution with the HEBIS scan, the investigators can evaluate the impact of radiation dose on liver function for different dose levels in liver (sub)volumes. This analysis will refine existing dose-effect relationships, enabling more tailored treatment of liver metastases in the future. Ten to fifteen patients will be included to assess functional liver imaging using HEBIS before their treatment and 3 to 4 months after their treatment.

Вмешательства

• Другое Functional liver imaging using hepatobiliary scintigraphy (HEBIS)
  The Hepatobiliary scintigraphy (HEBIS) or HIDA scan is a nuclear imaging technique that uses \[99mTc\]Tc-mebrofenin, a iminodiacetic acid (IDA) agent, which is a lidocaine analogue that is taken up by hepatocytes and is eliminated in the biliary tract (Arntz, 2023). This functional liver scan quantitatively assesses liver function of which the potential will be tested to measure liver function before and after radiotherapy.

Первичные конечные точки

• Dose-effect relationship between radiation dose and liver function by comparing the change in liver function before and after SBRT [Срок оценки: This is measured at baseline, before treatment, and after 3-4 months after treatment.]

Критерии участия

Критерии включения

• Patient treated for a liver metastasis with SBRT with treatment prescription of 3 x 20 Gy
• Able to provide informed consent prior to any study specific procedure

Критерии исключения

• WHO > 2
• Pregnancy
• Prior radiation therapy of the liver
• Lactation, unable to substitute for 24 hours
• Inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions

Exclusion criteria for HEBIS scan:

• GFR < 30 ml/min/1.73m2
• < 2 weeks after antiviral eradication therapy for hepatitis C
• Bilirubine > 30 µmol/l
• Relative contra-indications (possibly affecting liver function): opiates, barbiturates, somatostatine, colestyramine, rifampicine, atropine

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 1 центр

• Antoni van Leeuwenhoek — Amsterdam

Публикации

• Arntz PJW, Deroose CM, Marcus C, Sturesson C, Panaro F, Erdmann J, Manevska N, Moadel R, de Geus-Oei LF, Bennink RJ. Joint EANM/SNMMI/IHPBA procedure guideline for [99mTc]Tc-mebrofenin hepatobiliary scintigraphy SPECT/CT in the quantitative assessment of the future liver remnant function. HPB (Oxford). 2023 Oct;25(10):1131-1144. doi: 10.1016/j.hpb.2023.06.001. Epub 2023 Jun 2. PMID 37394397

Идентификаторы

NCT: NCT07033364 · N25FAF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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