RecruitingNot Applicable

MR-informed Stereotactic Radiotherapy for Treatment of Ultracentral Lung Tumours Utilising a Dedicated MR-simulator for Daily Adaptation Followed by CBCT-guided Treatment Delivery

Switzerland11 participantsStarted 2025-07-31

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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); * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility measured as a successful delivery of MR-informed radiotherapy per fraction using an MRI-adapted plan and CBCT image-guidance.

Timeframe: From enrollment to the end of treatment after 2-3 weeks (depending on tumour).

Trial details

NCT IDNCT06815289

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Nicolaus Andratschke, Prof. Dr. med.

+41 44 255 35 66 Nicolaus.Andratschke@usz.ch

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