Functional Liver After SBRT

NCT ID: NCT07033364

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-21
• Study Completion Date: 2026-07-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Functional liver imaging using hepatobiliary scintigraphy (HEBIS)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Antoni van Leeuwenhoek

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

M. Nowee, MD, PhD

Role: CONTACT

m.nowee@nki.nl

020-5129111

J. Peltenburg, MD

Role: CONTACT

j.peltenburg@nki.nl

Facility Contacts

Nowee

Role: primary

ev.schouten@nki.nl

+31205129111

References

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.

Reference Type: BACKGROUND

PMID: 37394397 (View on PubMed)

Other Identifiers

N25FAF

Identifier Type: -

Identifier Source: org_study_id