Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

Functional Liver After SBRT

NCT07033364 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2025-07-21
Last updated
2025-08-20

Condition(s) studied

Liver Metastases

Investigational drug(s) / intervention(s)

Functional liver imaging using hepatobiliary scintigraphy (HEBIS)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Dose-effect relationship between radiation dose and liver function by comparing the change in liver function before and after SBRT — This is measured at baseline, before treatment, and after 3-4 months after treatment.

Trial sites (1)

FacilityCityRegionStatus
Antoni van Leeuwenhoek Amsterdam Netherlands Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07033364 on ClinicalTrials.gov ↗ ← All trials in the Netherlands