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Recruiting NCT04172753

Feasibility of Online MR-guided Radiotherapy on a 1.5T MR-Linac

No phase Interventional Rectal Cancer Head and Neck Cancer Liver Cancer Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherapy on the MR-Linac, Imaging on the MR Linac.
Who it may be relevant to
Registry conditions: Rectal Cancer, Head and Neck Cancer, Liver Cancer, Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Feasibility of Imaging and Radiotherapy on a Novel 1.5 T Hybrid Magnetic Resonance Imaging - Linear Accelerator System (MR-Linac)

Overview

This study investigates the feasibility of imaging and treatment on a novel 1.5 T MR-Linac radiotherapy hybrid device.

Detailed description

Novel hybrid devices combine magnetic resonance imaging (MRI) and a linear accelerator in a single device. The superior soft tissue contrast compared with cone-beam computed tomography based treatment and the possibility for daily plan adaptation promise a higher precision of treatment, better target volume coverage and normal tissue sparing. In a first step the present study will test the feasibility of imaging and treatment on the 1.5 T MR-Linac.

Interventions

  • Radiation Radiotherapy on the MR-Linac
    Radiotherapy is performed on the 1.5 T MR Linac
  • Diagnostic test Imaging on the MR Linac
    Only imaging performed on the MR Linac

Primary outcome measures

  • Feasibility of online MR guided Radiotherapy [Time frame: During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)]
Secondary outcome measures (1)
  • Time analysis [Time frame: During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)]

Eligibility criteria

Inclusion criteria

  • existing indication for radiation therapy
  • minimum age 18 years, no upper age limit
  • capacity for consent
  • Informed consent

Exclusion criteria

  • contraindication for MRI (claustrophobia, metallic implants not applicable for MRI
  • pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • University Hospital Tübingen, Department of Radiation Oncology — Tübingen

Publications

  • Boeke S, Habrich J, Kubler S, Boldt J, Schick F, Nikolaou K, Kubler J, Gani C, Niyazi M, Zips D, Thorwarth D. Longitudinal assessment of diffusion-weighted imaging during magnetic resonance-guided radiotherapy in head and neck cancer. Radiat Oncol. 2025 Jan 29;20(1):15. doi: 10.1186/s13014-025-02589-9. PMID 39881423
  • Potkrajcic V, Gani C, Fischer SG, Boeke S, Niyazi M, Thorwarth D, Voigt O, Schneider M, Monnich D, Kubler S, Boldt J, Hoffmann E, Paulsen F, Mueller AC, Wegener D. Online Adaptive MR-Guided Ultrahypofractionated Radiotherapy of Prostate Cancer on a 1.5 T MR-Linac: Clinical Experience and Prospective Evaluation. Curr Oncol. 2024 May 9;31(5):2679-2688. doi: 10.3390/curroncol31050203. PMID 38785484

Identifiers

NCT: NCT04172753 · 659/2017BO1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗