Primary Objective: to determine the dose effect relationship between radiation dose and liver function by comparing the change in liver function after SBRT in whole liver and liver sub-volumes receiving a low/medium/high doses of radiation.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p>To determine the change in liver function after SBRT in whole liver and regional liver function sub-volumes receiving a low/medium/high dose by measuring the hepatic mebrofenin uptake rate (MUR) divided by the body surface area (BSA) before and 3-4 months after SBRT.</p>
Secondary outcome
<p>not applicable</p>
Background summary
In this study, we aim to determine the dose-effect relationship between radiation dose and liver function by performing a HEBIS scan before and after SBRT. HEBIS is a nuclear imaging technique that uses [99mTc]Tc-mebrofenin to quantitatively assess liver function. HEBIS better predicts the risk of postsurgical liver failure compared to volumetry alone and is implemented in clinical practice before surgery.
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 [Pursley, 2020], while liver tissue receiving doses above 15 Gy will retain some function [Howells, 2012].
By associating the 3D radiation dose distribution with the HEBIS scan, we can evaluate the impact of radiation dose on liver function for different dose levels. This analysis will refine existing dose-effect relationships, enabling more tailored treatment of liver metastases in the future.
Study objective
Primary Objective: to determine the dose effect relationship between radiation dose and liver function by comparing the change in liver function after SBRT in whole liver and liver sub-volumes receiving a low/medium/high doses of radiation.
Study design
This single-center study will be conducted at the NKI-AVL and follows the design of a prospective diagnostic pilot study.
Intervention
HEBIS-scan
Study burden and risks
Participation in this study has no adverse consequences or risks. However, the study does require additional time, as two HEBIS scans will be performed. For the HEBIS scans, an intravenous line (IV) will need to be placed, which may cause some pain, bruising, or (in rare cases) an infection. Additionally, the study involves the use of a radioactive substance and a SPECT-CT scan (the HEBIS scan), which involves exposure to X-ray radiation."
EAC Schouten
Plesmanlaan 121
Amsterdam 1066 CX
Netherlands
0205129111
m.nowee@nki.nl
EAC Schouten
Plesmanlaan 121
Amsterdam 1066 CX
Netherlands
0205129111
m.nowee@nki.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- Patient treated for a liver metastasis with SBRT with treatment prescription of 3 x 20 Gy.
- Age ≥ 18 years
- Able to provide signed written 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.
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Research portal | NL-009268 |