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

NCT06815289 | Recruiting

• 1 other identifier: RAO-24-034
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Lung Cancer or Secondary Lung Metastases

Keywords

ultracentral lung tumour

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

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.

Radiation: MR-informed stereotactic radiotherapy

Interventions

MR-informed stereotactic radiotherapy RADIATION

MR-informed stereotactic radiotherapy for treatment of ultracentral lung tumours utilising a dedicated MR-simulator for daily adaptation followed by CBCT-guided treatment delivery.

Single group study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

RECRUITING

Study Officials

• Nicolaus Andratschke, Prof. Dr. med.

  University of Zurich

  STUDY DIRECTOR

Central Study Contacts

Nicolaus Andratschke, Prof. Dr. med.

CONTACT

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

Lena Kretzschmar, Dr. med.

CONTACT

+41 44 255 35 66; Lena.Kretzschmar@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)