ClinicalTrials.gg
RecruitingNCT04172753Updated Nov 21, 2019

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

An interventional study of Radiotherapy on the MR-Linac and Imaging on the MR Linac in Rectal Cancer, Head and Neck Cancer and Liver Cancer, sponsored by University Hospital Tuebingen. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-21.

Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2022, 4 years 5 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 5 months after the study started (first participant enrolled May 2018, registered Nov 2019).
  • Started May 2018; still recruiting 8 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
472
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Rectal Cancer
  • Head and Neck Cancer
  • Liver Cancer
  • Breast Cancer
  • Prostate Cancer
  • Oligometastasis
  • Esophageal Cancer

Keywords

  • Radiotherapy
  • Adaptive Radiotherapy
03

In context

Rectal Neoplasms

1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.

This study's planned enrollment of 472 is above the median of 66 across 1,330 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • contraindication for MRI (claustrophobia, metallic implants not applicable for MRI
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
472 participants (estimated)

Study arms

  • Experimental
    Rectal and anal cancer

    In this arm patients with rectal and anal cancer are recruited.

    Radiation: Radiotherapy on the MR-Linac

  • Experimental
    Prostate cancer

    In this arm patients with prostate cancer are recruited.

    Radiation: Radiotherapy on the MR-Linac

  • Experimental
    Head and neck cancer

    In this arm patients with head and neck cancers are recruited.

    Radiation: Radiotherapy on the MR-Linac

  • Experimental
    Esophageal cancer

    In this arm patients with esophageal cancer are recruited.

    Radiation: Radiotherapy on the MR-Linac

  • Experimental
    Breast Cancer

    In this arm patients with breast cancer are recruited.

    Radiation: Radiotherapy on the MR-Linac

  • Experimental
    Central nervous system tutors

    In this arm patients with tumors of the central nervous system are recruited.

    Radiation: Radiotherapy on the MR-Linac

  • Experimental
    Palliative treatments

    In this arm patients with palliative treatments are recruited.

    Radiation: Radiotherapy on the MR-Linac

  • Experimental
    Other

    In this arm patients with other tumors are recruited.

    Radiation: Radiotherapy on the MR-Linac

  • Experimental
    Imaging only

    In this arm patients receive only imaging on the MR-Linac

    Diagnostic Test: Imaging on the MR Linac

Interventions

  • RadiationRadiotherapy on the MR-Linac

    Radiotherapy is performed on the 1.5 T MR Linac

  • Diagnostic testImaging on the MR Linac

    Only imaging performed on the MR Linac

06

What researchers measure

Primary outcomes

  1. Feasibility of online MR guided Radiotherapy

    Treatment of a patient is considered feasible when 85% of treatments were completed as planned in this patient

    Time frame: During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)

Secondary outcomes

  1. Time analysis

    Time required for online MR guided radiotherapy

    Time frame: During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 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. PubMed 38785484 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04172753
Responsible party
Dr. Cihan Gani (Lead of gastrointestinal radiation oncology, University Hospital Tuebingen) — Principal investigator
First posted
Nov 21, 2019
Start date
May 9, 2018
Primary completion
May 9, 2022 (estimated)
Completion
May 9, 2027 (estimated)
Last update
Nov 21, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion