Liver MetastasesFAFORNCT07033364
Functional Liver After SBRT
An observational study of Liver Metastases, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases
- What is being tested?
- Functional liver imaging using hepatobiliary scintigraphy (HEBIS)
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jul 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
- GFR < 30 ml/min/1.73m2
Show all 9Show fewer
- < 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
J. Peltenburg, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Antoni van Leeuwenhoek
Amsterdam
Nowee, +31205129111, ev.schouten@nki.nl
About this study
Official title: Changes in Functional Liver Tissue After Liver Metastasis Irradiation: Pilot Study of Functional Imaging Before and After Stereotactic Body Radiotherapy
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.
- Conditions
- Liver Metastases
- Being tested
- Functional liver imaging using hepatobiliary scintigraphy (HEBIS)
- Keywords
- liver function test, functional liver imaging, hepatobiliary scintigraphy, dose effect relationship, radiotherapy, SBRT, nuclear medicine, liver function, HEBIS, HIDA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional liver imaging using hepatobiliary scintigraphy (HEBIS)Other
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 group | Role | What they receive |
|---|---|---|
| Patients with liver metastases | 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 in the Netherlands. Receives: Other: Functional liver imaging using hepatobiliary scintigraphy (HEBIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-effect relationship between radiation dose and liver function by comparing the change in liver function before and after SBRT
Measured: This is measured at baseline, before treatment, and after 3-4 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start21 Jul 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033364
- Sponsor's protocol ID
- N25FAF
- Acronym
- FAFOR
- Status last verified
- Aug 2025
- First submitted
- 13 Jun 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arntz PJW, Deroose CM, Marcus C, Sturesson C, Panaro F, Erdmann J, Manevska N, Moadel R, de Geus-Oei LF, Bennink RJ. Joint EANM/SNMMI/IHPBA procedure guideline for [99mTc]Tc-mebrofenin hepatobiliary scintigraphy SPECT/CT in the quantitative assessment of the future liver remnant function. HPB (Oxford). 2023 Oct;25(10):1131-1144. doi: 10.1016/j.hpb.2023.06.001. Epub 2023 Jun 2.
PubMed 37394397
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Functional Liver Tissue After Liver Metastasis Irradiation: Pilot Study of Functional Imaging Before and After Stereotactic Body Radiotherapy
- ClinicalTrials.gov ID
- NCT07033364
- Acronym / sponsor ID
- FAFOR / N25FAF
- Conditions
- Liver Metastases
- Keywords
- liver function test, functional liver imaging, hepatobiliary scintigraphy, dose effect relationship, radiotherapy, SBRT, nuclear medicine, liver function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with liver metastases | – | Other: Functional liver imaging using hepatobiliary scintigraphy (HEBIS)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 in the Netherlands. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients with liver metastases |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Background: PubMed 37394397Arntz PJW, Deroose CM, Marcus C, Sturesson C, Panaro F, Erdmann J, Manevska N, Moadel R, de Geus-Oei LF, Bennink RJ. Joint EANM/SNMMI/IHPBA procedure guideline for [99mTc]Tc-mebrofenin hepatobiliary scintigraphy SPECT/CT in the quantitative assessment of the future liver remnant function. HPB (Oxford). 2023 Oct;25(10):1131-1144. doi: 10.1016/j.hpb.2023.06.001. Epub 2023 Jun 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
J. Peltenburg, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Metastases, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact M. Nowee, MD, PhD (020-5129111, m.nowee@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07033364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.