Functional Liver After SBRT

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07033364

Acronym

FAFOR

Enrollment

Registered

2025-06-24

Start date

2025-07-21

Completion date

2026-07-31

Last updated

2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Metastases

Keywords

liver function test, functional liver imaging, hepatobiliary scintigraphy, dose effect relationship, radiotherapy, SBRT, nuclear medicine, liver function, HEBIS, HIDA

Brief summary

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

OTHERFunctional 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Netherlands

Contacts

Primary ContactM. Nowee, MD, PhD

m.nowee@nki.nl020-5129111

Backup ContactJ. Peltenburg, MD

j.peltenburg@nki.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026