Functional Liver After SBRT

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

WHO > 2

Pregnancy

Prior radiation therapy of the liver

Lactation, unable to substitute for 24 hours

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Functional liver imaging using hepatobiliary scintigraphy (HEBIS)

    Other intervention

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Patients with liver metastases1 intervention

Trial outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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