Actively Recruiting

Age: 18Years +
All Genders
NCT07033364

Functional Liver After SBRT

Led by The Netherlands Cancer Institute · Updated on 2025-08-20

15

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Functional Liver After SBRT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • WHO performance status greater than 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
  • Glomerular filtration rate (GFR) less than 30 ml/min/1.73m2
  • Less than 2 weeks after antiviral eradication therapy for hepatitis C
  • Bilirubin level greater than 30 mol/l
  • Use of medications possibly affecting liver function: opiates, barbiturates, somatostatin, colestyramine, rifampicine, atropine

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Trial Site Locations

Total: 1 location

1

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Actively Recruiting

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Research Team

M

M. Nowee, MD, PhD

CONTACT

J

J. Peltenburg, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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