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NCT Number: NCT07033364

Functional Liver After SBRT

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional liver imaging using hepatobiliary scintigraphy (HEBIS)

Other

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 outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

J. Peltenburg, MD

CONTACT

[email protected]

M. Nowee, MD, PhD

CONTACT

[email protected]

020-5129111

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

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

Acronym: FAFOR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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