Liver function after stereotactic body radiotherapy (SBRT)
Official title: Changes in Functional Liver Tissue After Liver Metastasis Irradiation: Pilot Study of Functional Imaging Before and After Stereotactic Body Radiotherapy
Run by The Netherlands Cancer Institute · NCT07033364 · Data updated 2026-11-12
This project will use a special liver scan (HEBIS) before and after SBRT to see how different radiation doses affect liver function in people treated for liver metastases.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Amsterdam) |
| Status | Recruiting |
| Started | July 21, 2025 |
| Main results expected | April 30, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | August 20, 2025 |
| Trial ID | NCT07033364 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with liver metastases treated with SBRT at a 3 x 20 Gy prescription who can consent and comply with HEBIS scanning and do not have prior liver radiotherapy or disqualifying lab values.
✕Probably not a fit
Patients who are pregnant, have very poor baseline liver or kidney function, prior liver radiation, or who do not receive the specified SBRT regimen or cannot undergo HEBIS are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with liver metastases treated with a three‑fraction SBRT prescription (3 x 20 Gy) will receive hepatobiliary scintigraphy (HEBIS) scans before and after treatment to map regional liver function. Investigators will link the 3D radiation dose distribution to local HEBIS measurements to determine dose–effect relationships for liver subvolumes. Results aim to clarify how doses below and above current constraints (e.g., 15 Gy in 3 fractions) impact retained liver function. Standard eligibility and safety exclusions apply, including limits on renal function, bilirubin, pregnancy, and prior liver radiotherapy.
Why it matters
Potential benefit: If successful, this work could refine radiation planning limits to better protect functioning liver tissue and reduce the risk of post‑treatment liver failure.
How similar studies have gone: Functional liver imaging like HEBIS has previously predicted post‑surgical liver failure better than volume measures, but using it to define detailed local dose–effect relationships after SBRT is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 Exclusion criteria for HEBIS scan: * 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
Where it's running
-
Antoni van Leeuwenhoek
Amsterdam, Netherlands Recruiting
Study contacts
- Study coordinator: M. Nowee, MD, PhD
- Email: m.nowee@nki.nl
- Phone: 020-5129111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.