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Recruiting NCT07033364

Functional Liver After SBRT

— Observational Liver Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Functional liver imaging using hepatobiliary scintigraphy (HEBIS).
Who it may be relevant to
Registry conditions: Liver Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Antoni van Leeuwenhoek — Amsterdam

Publications

  • 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

Identifiers

NCT: NCT07033364 · N25FAF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗