Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06815289

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

Led by University of Zurich · Updated on 2025-08-11

11

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent according to Swiss law and ICH/GCP regulations before any trial procedures
  • Ultracentral primary or secondary lung lesion(s) confirmed by imaging and histology, suitable for SBRT
  • Indication for SBRT based on multidisciplinary tumor board recommendation or clinical guidelines
  • Age 18 years or older
  • Willing and able to comply with scheduled visits, treatment, and trial procedures
Not Eligible

You will not qualify if you...

  • Large body size incompatible with MRI-simulator bore
  • Contraindications for MRI
  • Previous radiation therapy overlapping planned SBRT area
  • Women who are pregnant or breastfeeding
  • Intention to become pregnant during the trial
  • Lack of safe contraception for women of childbearing potential
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow trial procedures, e.g., due to language barriers
  • Enrollment of investigator, family members, employees, or other dependent persons

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Zurich

Zurich, Switzerland

Actively Recruiting

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Research Team

N

Nicolaus Andratschke, Prof. Dr. med.

CONTACT

L

Lena Kretzschmar, Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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