Liver function after stereotactic body radiotherapy (SBRT)
Changes in Functional Liver Tissue After Liver Metastasis Irradiation: Pilot Study of Functional Imaging Before and After Stereotactic Body Radiotherapy
The Netherlands Cancer Institute · NCT07033364
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 |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT07033364 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Amsterdam
- Antoni van Leeuwenhoek — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Study coordinator: M. Nowee, MD, PhD
- Email: m.nowee@nki.nl
- Phone: 020-5129111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Metastases, liver function test, functional liver imaging, hepatobiliary scintigraphy, dose effect relationship, radiotherapy, SBRT, nuclear medicine