Primary Lung Cancer or Secondary Lung MetastasesMUSICNCT06815289
MR-informed Stereotactic Radiotherapy for Treatment of Ultracentral Lung Tumours Utilising a Dedicated MR-simulator for Daily Adaptation Followed by CBCT-guided Treatment Delivery
A study testing MR-informed stereotactic radiotherapy in people with Primary Lung Cancer or Secondary Lung Metastases, run by University of Zurich at 1 site in Switzerland.
Trial summary
Stereotactic body radiotherapy (SBRT) is the preferred treatment for inoperable early-stage non-small cell lung cancer (NSCLC) and for operable cases when patients decline surgery, offering local control (LC) rates of 80-97%. SBRT is also used in oligometastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Lung Cancer or Secondary Lung Metastases
- What is being tested?
- MR-informed stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Jul 2025to 31 Dec 2028
- 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 according to Swiss law and ICH/GCP regulations signed and dated by the participant and the investigator before any trial specific procedures (Informed Consent Form);
- Ultracentral (PTV-overlap with bronchial tree, trachea/carina and/or esophagus) primary or secondary lung lesion(s) from a histologically confirmed malignancy, confirmed by imaging and amenable for SBRT;
- Indication for SBRT based on a multidisciplinary tumour board recommendation and / or clinical practice guideline;
- Age≥18 years old;
- Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.
Who cannot join
- Large body size that would not fit the MRI-simulator bore;
- Contraindications for MRI;
- Previous radiation therapy directly overlapping with planned SBRT (type I re-irradiation);
- Women who are pregnant or breast feeding;
- Intention to become pregnant during the trial;
- Lack of safe contraception (Female participants who underwent hysterectomy and/or bilateral oophorectomy or post-menopausal for longer than 2 years are not considered as being of child bearing potential);
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- Known or suspected non-compliance, drug or alcohol abuse;
- Inability to follow the procedures of the trial, e.g. due to language problems of the participant;
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich
Nicolaus Andratschke, +41 44 255 35 66, nicolaus.andratschke@usz.ch
Lena Kretzschmar, Lena.Kretzschmar@usz.ch
About this study
Stereotactic body radiotherapy (SBRT) is the preferred treatment for inoperable early-stage non-small cell lung cancer (NSCLC) and for operable cases when patients decline surgery, offering local control (LC) rates of 80-97%. SBRT is also used in oligometastatic cancer. However, its safety and efficacy for ultra-central lung tumours, near the proximal bronchial tree (PBT) and/or esophagus, remain debated. SBRT targeting these tumours has been associated with higher risk of severe toxicity, including pulmonary hemorrhage and pneumonitis. The term "ultra-central lung tumours" refers to tumours abutting the PBT, trachea, or esophagus.
MR-guided online adaptive radiotherapy has been implemented recently using MR-linac technology, where MR-imaging is combined with linac technology in hybrid systems. These systems offer MR imaging for online adaptive radiotherapy within the treatment room and with the patient in treatment position. Despite results regarding technical and clinical feasibility being promising, the high costs of MR-linac systems and the demands for staffing resources of MR-linacs are limiting a broader implementation of this technology. The MAGELLAN trial is currently investigating MR-linac based SBRT in ultracentral lung tumours to reduce severe toxicity, with outcomes pending.
At the Department of Radiation Oncology, University Hospital Zurich, MRI-simulations for RT planning using a dedicated scanner have been performed since 2023 for different tumour entities. We have developed and implemented an MRI-based RT online adaptive re-planning workflow followed by RT delivered at a CBCT-guided, conventional linac. We now aim to expand this MR-informed workflow to online adaptive RT for ultracentral lung tumours. With this study, we will investigate the feasibility of MR-informed, online adaptive SBRT for ultracentral lung tumours using a dedicated MR simulator and treatment delivery using conventional CBCT-linac technology.
Read the detailed description
Patients will be registered, screened, and checked for their eligibility. Upon signing the written informed consent patients recognised eligible will be enrolled in the study. Patients in treatment position will undergo MRI-simulation using two dedicated MR-scanners: A 0.55 T machine that will also be used for daily adaptations during treatment, and a 1.5 T machine for the standard-of-care planning simulation. Additionally, a standard-of-care planning CT with contrast-enhanced 3DCT and native 4DCT will be performed. Target and OARs will be identified and delineated on the MRI scan, while planning CT-sequences will be co-registered to gain additional information on (breathing) motion. An SBRT treatment plan will be generated. For GTVs with movement > 5 mm in either direction over the breathing phases, the treatment will be carried out in expiration-breath-hold-technique. On the 1st day of treatment, a new MRI scan in treatment position will be acquired on the dedicated MR simulator, and co-registered with the original one. The original target and OAR contours will be propagated to the new image set using rigid and deformable image registration. The contours will be adapted by a radiation oncologist to changes detected within the MRI of the day. The original SBRT treatment plan will be adapted by a medical physicist to the changed and adapted anatomy of targets and OARs by plan re-optimisation. Upon the plan approval by the treating radiation oncologist, patient-specific quality assurance (PSQA) will be performed. Should the target volumes and OARs prove unchanged compared to the simulation, the radiation oncologist may omit contour adaptation and the workflow may proceed in a shortened fashion; the original plan will then be used for dose re-calculation on the images of the day. Patients will be transferred from the MR scanner with a dedicated couch-to-couch-shuttle-system and will be set up on the treatment table of the linac. Their position will be verified by matching the adapted contours of the day to the linac CBCT. For highly mobile tumours that are irradiated in breath-hold the breath-hold position will be verified with repetitive CBCTs as is standard of care. It will be followed by treatment delivery. The procedure will be repeated before delivery of each SBRT fraction. On the first two days an additional MR scan will be performed directly before the CBCT imaging to verify the anatomy of the day. This will be done by matching to the tumour and visual checking of the contours. In case of motion this will be repeated the following days. During simulation and once weekly during treatment an additional (second) MR-scan, as well as additional functional imaging will be acquired on the dedicated MR scanners. Patients with different fractionation schemes can be included in the study. The standard prescription is 50 Gy in 10 fractions (4-5 fractions/week) @80% IDL to the planning target volume (PTV) for primary tumours of the lung, or 45 - 49.5 Gy in 10 - 11 fractions (4-5 fractions/week) @80% IDL to the planning target volume (PTV) for secondary tumours/metastases of the lung. However, other SBRT fractionations can be included as well.
- Being tested
- MR-informed stereotactic radiotherapy
- Keywords
- ultracentral lung tumour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-informed stereotactic radiotherapyRadiation
MR-informed stereotactic radiotherapy for treatment of ultracentral lung tumours utilising a dedicated MR-simulator for daily adaptation followed by CBCT-guided treatment delivery.
| Study group | Role | What they receive |
|---|---|---|
| Single group study | Other | Patients receive a standard fractionation of 10 fractions per treatment course, although other fractionation schemes are allowed within the scope of this study. Receives: Radiation: MR-informed stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measured as a successful delivery of MR-informed radiotherapy per fraction using an MRI-adapted plan and CBCT image-guidance.
Every treatment fraction having passed the point of entry into the adaptive workflow will be analysed for this endpoint. The point of entry is defined as the completion of the first MRI for adaptation purposes on that given day. If the adaptive workflow has to be broken off after the completion of this MRI for any reason, and the fraction is either administered outside of the MR-informed workflow or has to be postponed/cancelled, it is counted as non-feasible. The only exception to this is the initial (planning) treatment simulation: If this simulation cannot be fully performed for any reason, the patient will be censored and not included in the feasibility analysis. If a treatment fraction was non-feasible it remains at the discretion of the treating physician whether the next treatment fraction will be administered inside the MR-informed workflow, or if all remaining fractions will be given outside of it according to standard-of-care.
Measured: From enrollment to the end of treatment after 2-3 weeks (depending on tumour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start31 Jul 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Lung Cancer or Secondary Lung MetastasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this study, we will investigate the feasibility of MR-informed, online adaptive SBRT for ultracentral lung tumours using a dedicated MR simulator and treatment delivery using conventional CBCT-linac technology.
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolaus Andratschke, Prof. Dr. med., Study director, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815289
- Sponsor's protocol ID
- RAO-24-034
- Acronym
- MUSIC
- Status last verified
- Aug 2025
- First submitted
- 3 Feb 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-informed Stereotactic Radiotherapy for Treatment of Ultracentral Lung Tumours Utilising a Dedicated MR-simulator for Daily Adaptation Followed by CBCT-guided Treatment Delivery
- ClinicalTrials.gov ID
- NCT06815289
- Acronym / sponsor ID
- MUSIC / RAO-24-034
- Keywords
- ultracentral lung tumour
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Feb 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.
Stereotactic body radiotherapy (SBRT) is the preferred treatment for inoperable early-stage non-small cell lung cancer (NSCLC) and for operable cases when patients decline surgery, offering local control (LC) rates of 80-97%. SBRT is also used in oligometastatic cancer. However, its safety and efficacy for ultra-central lung tumours, near the proximal bronchial tree (PBT) and/or esophagus, remain debated. SBRT targeting these tumours has been associated with higher risk of severe toxicity, including pulmonary hemorrhage and pneumonitis. The term "ultra-central lung tumours" refers to tumours abutting the PBT, trachea, or esophagus.
MR-guided online adaptive radiotherapy has been implemented recently using MR-linac technology, where MR-imaging is combined with linac technology in hybrid systems. These systems offer MR imaging for online adaptive radiotherapy within the treatment room and with the patient in treatment position. Despite results regarding technical and clinical feasibility being promising, the high costs of MR-linac systems and the demands for staffing resources of MR-linacs are limiting a broader implementation of this technology. The MAGELLAN trial is currently investigating MR-linac based SBRT in ultracentral lung tumours to reduce severe toxicity, with outcomes pending.
At the Department of Radiation Oncology, University Hospital Zurich, MRI-simulations for RT planning using a dedicated scanner have been performed since 2023 for different tumour entities. We have developed and implemented an MRI-based RT online adaptive re-planning workflow followed by RT delivered at a CBCT-guided, conventional linac. We now aim to expand this MR-informed workflow to online adaptive RT for ultracentral lung tumours. With this study, we will investigate the feasibility of MR-informed, online adaptive SBRT for ultracentral lung tumours using a dedicated MR simulator and treatment delivery using conventional CBCT-linac technology.
Detailed description
Patients will be registered, screened, and checked for their eligibility. Upon signing the written informed consent patients recognised eligible will be enrolled in the study. Patients in treatment position will undergo MRI-simulation using two dedicated MR-scanners: A 0.55 T machine that will also be used for daily adaptations during treatment, and a 1.5 T machine for the standard-of-care planning simulation. Additionally, a standard-of-care planning CT with contrast-enhanced 3DCT and native 4DCT will be performed. Target and OARs will be identified and delineated on the MRI scan, while planning CT-sequences will be co-registered to gain additional information on (breathing) motion. An SBRT treatment plan will be generated. For GTVs with movement > 5 mm in either direction over the breathing phases, the treatment will be carried out in expiration-breath-hold-technique. On the 1st day of treatment, a new MRI scan in treatment position will be acquired on the dedicated MR simulator, and co-registered with the original one. The original target and OAR contours will be propagated to the new image set using rigid and deformable image registration. The contours will be adapted by a radiation oncologist to changes detected within the MRI of the day. The original SBRT treatment plan will be adapted by a medical physicist to the changed and adapted anatomy of targets and OARs by plan re-optimisation. Upon the plan approval by the treating radiation oncologist, patient-specific quality assurance (PSQA) will be performed. Should the target volumes and OARs prove unchanged compared to the simulation, the radiation oncologist may omit contour adaptation and the workflow may proceed in a shortened fashion; the original plan will then be used for dose re-calculation on the images of the day. Patients will be transferred from the MR scanner with a dedicated couch-to-couch-shuttle-system and will be set up on the treatment table of the linac. Their position will be verified by matching the adapted contours of the day to the linac CBCT. For highly mobile tumours that are irradiated in breath-hold the breath-hold position will be verified with repetitive CBCTs as is standard of care. It will be followed by treatment delivery. The procedure will be repeated before delivery of each SBRT fraction. On the first two days an additional MR scan will be performed directly before the CBCT imaging to verify the anatomy of the day. This will be done by matching to the tumour and visual checking of the contours. In case of motion this will be repeated the following days. During simulation and once weekly during treatment an additional (second) MR-scan, as well as additional functional imaging will be acquired on the dedicated MR scanners. Patients with different fractionation schemes can be included in the study. The standard prescription is 50 Gy in 10 fractions (4-5 fractions/week) @80% IDL to the planning target volume (PTV) for primary tumours of the lung, or 45 - 49.5 Gy in 10 - 11 fractions (4-5 fractions/week) @80% IDL to the planning target volume (PTV) for secondary tumours/metastases of the lung. However, other SBRT fractionations can be included as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this study, we will investigate the feasibility of MR-informed, online adaptive SBRT for ultracentral lung tumours using a dedicated MR simulator and treatment delivery using conventional CBCT-linac technology.
| Arm | Type | Receives |
|---|---|---|
| Single group study | Other | Radiation: MR-informed stereotactic radiotherapyPatients receive a standard fractionation of 10 fractions per treatment course, although other fractionation schemes are allowed within the scope of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent according to Swiss law and ICH/GCP regulations signed and dated by the participant and the investigator before any trial specific procedures (Informed Consent Form);
- Ultracentral (PTV-overlap with bronchial tree, trachea/carina and/or esophagus) primary or secondary lung lesion(s) from a histologically confirmed malignancy, confirmed by imaging and amenable for SBRT;
- Indication for SBRT based on a multidisciplinary tumour board recommendation and / or clinical practice guideline;
- Age≥18 years old;
- Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.
Key exclusion criteria (9 listed)
- Large body size that would not fit the MRI-simulator bore;
- Contraindications for MRI;
- Previous radiation therapy directly overlapping with planned SBRT (type I re-irradiation);
- Women who are pregnant or breast feeding;
- Intention to become pregnant during the trial;
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 |
|---|---|---|
| MR-informed stereotactic radiotherapyMR-informed stereotactic radiotherapy for treatment of ultracentral lung tumours utilising a dedicated MR-simulator for daily adaptation followed by CBCT-guided treatment delivery. | Radiation | Single group study |
Primary outcome
Feasibility measured as a successful delivery of MR-informed radiotherapy per fraction using an MRI-adapted plan and CBCT image-guidance.
Time frame: From enrollment to the end of treatment after 2-3 weeks (depending on tumour).
Every treatment fraction having passed the point of entry into the adaptive workflow will be analysed for this endpoint. The point of entry is defined as the completion of the first MRI for adaptation purposes on that given day. If the adaptive workflow has to be broken off after the completion of this MRI for any reason, and the fraction is either administered outside of the MR-informed workflow or has to be postponed/cancelled, it is counted as non-feasible. The only exception to this is the initial (planning) treatment simulation: If this simulation cannot be fully performed for any reason, the patient will be censored and not included in the feasibility analysis. If a treatment fraction was non-feasible it remains at the discretion of the treating physician whether the next treatment fraction will be administered inside the MR-informed workflow, or if all remaining fractions will be given outside of it according to standard-of-care.
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 11 Aug 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.
Nicolaus Andratschke, Prof. Dr. med. study director
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-informed stereotactic radiotherapy in people with Primary Lung Cancer or Secondary Lung Metastases, run by University of Zurich at 1 site in Switzerland.
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 5 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 11 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 Switzerland. 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 Nicolaus Andratschke, Prof. Dr. med. (+41 44 255 35 66, Nicolaus.Andratschke@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility measured as a successful delivery of MR-informed radiotherapy per fraction using an MRI-adapted plan and CBCT image-guidance. (time frame: From enrollment to the end of treatment after 2-3 weeks (depending on tumour).). 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 11 Aug 2025.