HCC - Hepatocellular CarcinomaNCT06768242
Part of the Modern Art Study
A study testing Cone beam CT in people with HCC - Hepatocellular Carcinoma and Liver Metastases, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
One of the possible treatments for patients with liver tumours (hepatocellular carcinoma (HCC) or liver metastases) at the Erasmus MC is stereotactic body radiation therapy (SBRT) on the Cyberknife. To spare the organs at risk, suboptimal coverage of the planning target volume is sometimes accepted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Liver Metastases
- What is being tested?
- Cone beam CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2025to 31 Dec 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent;
- Patient discussed in multidisciplinary tumor board;
- Patient diagnosed with liver metastases and referred to the dept. of Radiotherapy for SBRT OR patient ≥65 years, diagnosed with HCC and referred to the dept. of Radiotherapy for SBRT;
- Able to comply with breath-hold requirements.
Who cannot join
- Eligibility for surgery, ablation or liver transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Linda Chen, MSc contact
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 CD
Alejandra Méndez Romero, MD, PhD, +31 (0)10 7035792, a.mendezromero@erasmusmc.nl
Linda Chen, MSc, l.chen@erasmusmc.nl
About this study
Official title: Inter- and Intra-fraction Fiducial Position Reproducibility in End-exhalation Breath Hold for Ethos Liver Radiotherapy - Part of the Modern Art Study
One of the possible treatments for patients with liver tumours (hepatocellular carcinoma (HCC) or liver metastases) at the Erasmus MC is stereotactic body radiation therapy (SBRT) on the Cyberknife. To spare the organs at risk, suboptimal coverage of the planning target volume is sometimes accepted. The Ethos treatment system is equipped with a novel cone-beam CT (CBCT), which provides higher quality images. This makes it possible to consider online adaptive radiotherapy with daily plan adaptation, potentially leading to a higher dose on the tumour whilst sparing the surrounding healthy tissue more.
Liver tumours move with the breathing motion. On the CyberKnife, a tracking technology is used to keep track of the tumour, but this is not available on the Ethos. Because of this, breath holds will be used for breathing management, but appropriate safety margins need to be established under the new treatment conditions. The aim of this study is to determine the reproducibility of the tumour position for each breath hold within a treatment fraction, and also between treatment fractions, which is a crucial component in the establishment of appropriate safety margins.
Read the detailed description
Rationale:
One of the possible treatments for patients with liver tumours (hepatocellular carcinoma (HCC) or liver metastases) at the Erasmus MC is stereotactic body radiation therapy (SBRT) on the Cyberknife. To spare the organs at risk, suboptimal coverage of the planning target volume is sometimes accepted on the Cyberknife. The Ethos therapy linear accelerator is equipped with a novel cone-beam CT (CBCT), which provides higher quality images. This makes it possible to consider online adaptive radiotherapy with daily plan adaptation, potentially leading to a higher dose on the tumour whilst sparing the surrounding healthy tissue more.
Objectives:
To determine inter- and intra-fraction fiducial and patient position reproducibility in order to determine appropriate safety margins for liver SBRT treatment on Ethos.
Study design:
A prospective, single arm cohort study.
Study population:
Ten patients, either with liver metastases (all ages), or age ≥ 65 years with HCC, who are referred to the department of Radiotherapy for SBRT, able to comply with breath-hold requirements and not eligible for liver transplantation or curative surgery.
Intervention:
Nine CBCTs for each patient in end-exhalation breath hold on t Main study parameters/endpoints: The primary parameters are inter- and intra-fraction fiducial position reproducibility on the Ethos.
- Conditions
- HCC - Hepatocellular Carcinoma, Liver Metastases
- Being tested
- Cone beam CT
- Keywords
- HCC - Hepatocellular Carcinoma, Stereotactic body radiation therapy, Breath hold, Liver metastases
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone beam CTRadiation
Each patient will undergo three cone beam CTs per session, and a total of three sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cone beam CT | Experimental | Single-arm study Receives: Radiation: Cone beam CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrafraction fiducial position reproducibility
The translation in mm in three directions (craniocaudal, left-right and anterior-posterior) of each of the fiducials in the second and third cone beam CT, compared to the first cone beam CT of each session.
Measured: Before or after three radiotherapy sessions over the course of treatment.
Interfraction fiducial position reproducibility
The translation in mm in three directions (craniocaudal, left-right and anterior-posterior) of each of the fiducials in each of the imaging sessions, compared to the planning CT that was made before the start of treatment.
Measured: Before or after three radiotherapy sessions over the course of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study startJan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandra Mendez Romero, Erasmus Medical Center
- Investigators
- Alejandra Méndez Romero, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768242
- Sponsor's protocol ID
- NL86070.078.24
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter- and Intra-fraction Fiducial Position Reproducibility in End-exhalation Breath Hold for Ethos Liver Radiotherapy - Part of the Modern Art Study
- ClinicalTrials.gov ID
- NCT06768242
- Acronym / sponsor ID
- NL86070.078.24
- Conditions
- HCC - Hepatocellular Carcinoma, Liver Metastases
- Keywords
- HCC - Hepatocellular Carcinoma, Stereotactic body radiation therapy, Breath hold, Liver metastases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jan 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.
One of the possible treatments for patients with liver tumours (hepatocellular carcinoma (HCC) or liver metastases) at the Erasmus MC is stereotactic body radiation therapy (SBRT) on the Cyberknife. To spare the organs at risk, suboptimal coverage of the planning target volume is sometimes accepted. The Ethos treatment system is equipped with a novel cone-beam CT (CBCT), which provides higher quality images. This makes it possible to consider online adaptive radiotherapy with daily plan adaptation, potentially leading to a higher dose on the tumour whilst sparing the surrounding healthy tissue more.
Liver tumours move with the breathing motion. On the CyberKnife, a tracking technology is used to keep track of the tumour, but this is not available on the Ethos. Because of this, breath holds will be used for breathing management, but appropriate safety margins need to be established under the new treatment conditions. The aim of this study is to determine the reproducibility of the tumour position for each breath hold within a treatment fraction, and also between treatment fractions, which is a crucial component in the establishment of appropriate safety margins.
Detailed description
Rationale:
One of the possible treatments for patients with liver tumours (hepatocellular carcinoma (HCC) or liver metastases) at the Erasmus MC is stereotactic body radiation therapy (SBRT) on the Cyberknife. To spare the organs at risk, suboptimal coverage of the planning target volume is sometimes accepted on the Cyberknife. The Ethos therapy linear accelerator is equipped with a novel cone-beam CT (CBCT), which provides higher quality images. This makes it possible to consider online adaptive radiotherapy with daily plan adaptation, potentially leading to a higher dose on the tumour whilst sparing the surrounding healthy tissue more.
Objectives:
To determine inter- and intra-fraction fiducial and patient position reproducibility in order to determine appropriate safety margins for liver SBRT treatment on Ethos.
Study design:
A prospective, single arm cohort study.
Study population:
Ten patients, either with liver metastases (all ages), or age ≥ 65 years with HCC, who are referred to the department of Radiotherapy for SBRT, able to comply with breath-hold requirements and not eligible for liver transplantation or curative surgery.
Intervention:
Nine CBCTs for each patient in end-exhalation breath hold on t Main study parameters/endpoints: The primary parameters are inter- and intra-fraction fiducial position reproducibility on the Ethos.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cone beam CT | Experimental | Radiation: Cone beam CTSingle-arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent;
- Patient discussed in multidisciplinary tumor board;
- Patient diagnosed with liver metastases and referred to the dept. of Radiotherapy for SBRT OR patient ≥65 years, diagnosed with HCC and referred to the dept. of Radiotherapy for SBRT;
- Able to comply with breath-hold requirements.
Key exclusion criteria (1 listed)
- Eligibility for surgery, ablation or liver transplantation.
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 |
|---|---|---|
| Cone beam CTEach patient will undergo three cone beam CTs per session, and a total of three sessions. | Radiation | Cone beam CT |
Primary outcome
Intrafraction fiducial position reproducibility
Time frame: Before or after three radiotherapy sessions over the course of treatment.
The translation in mm in three directions (craniocaudal, left-right and anterior-posterior) of each of the fiducials in the second and third cone beam CT, compared to the first cone beam CT of each session.
Interfraction fiducial position reproducibility
Time frame: Before or after three radiotherapy sessions over the course of treatment.
The translation in mm in three directions (craniocaudal, left-right and anterior-posterior) of each of the fiducials in each of the imaging sessions, compared to the planning CT that was made before the start of 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 10 Jan 2025.
- 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.
Linda Chen, MSc contact
Alejandra Méndez Romero, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone beam CT in people with HCC - Hepatocellular Carcinoma and Liver Metastases, run by Erasmus Medical Center 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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 Jan 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 Alejandra Méndez Romero, MD, PhD (+31 (0)10 7035792, a.mendezromero@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrafraction fiducial position reproducibility (time frame: Before or after three radiotherapy sessions over the course of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2025.