Functional Liver After SBRT

NCT07033364 | Recruiting

• 1 other identifier: N25FAF
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Metastases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Patients with liver metastases

Ten to fifteen patients with a single liver metastasis who will be treated with SBRT, will be included to assess functional imaging using HEBIS before and 3-4 months after their treatment (SBRT). Patients are included in a single institute in the Netherlands.

Other: Functional liver imaging using hepatobiliary scintigraphy (HEBIS)

Interventions

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.

Patients with liver metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ten to fifteen patients with a single liver metastasis who will be treated with SBRT, will be included to assess functional imaging using HEBIS before and 3-4 months after their treatment (SBRT). Patients are included in a single institute , NKI-AvL, in consecutive or convenient order.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, Netherlands

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Central Study Contacts

M. Nowee, MD, PhD

CONTACT

020-5129111; m.nowee@nki.nl

J. Peltenburg, MD

CONTACT

j.peltenburg@nki.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: July 21, 2025
• Primary Completion: April 30, 2026
• Study Completion: July 31, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)