Rectal CancerNCT04172753
Feasibility of Online MR-guided Radiotherapy on a 1.5T MR-Linac
A study testing Radiotherapy on the MR-Linac and Imaging on the MR Linac in people with Rectal Cancer and Head and Neck Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This study investigates the feasibility of imaging and treatment on a novel 1.5 T MR-Linac radiotherapy hybrid device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Head and Neck Cancer, Liver Cancer
- What is being tested?
- Radiotherapy on the MR-Linac and Imaging on the MR Linac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteGermany
- Study dates
- 9 May 2018to 9 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- existing indication for radiation therapy
- minimum age 18 years, no upper age limit
- capacity for consent
- Informed consent
Who cannot join
- contraindication for MRI (claustrophobia, metallic implants not applicable for MRI
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tübingen, Department of Radiation Oncology
Tübingen, Baden-Wurttemberg, 72076
Daniel Zips, MD, Prof, +49 (0) 7071 29-85990, ro-info@med.uni-tuebingen.de
Cihan Gani, MD, +49 (0)7071 29-82165, cihan.gani@med.uni-tuebingen.de
About this study
Official title: Feasibility of Imaging and Radiotherapy on a Novel 1.5 T Hybrid Magnetic Resonance Imaging - Linear Accelerator System (MR-Linac)
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.
- Conditions
- Rectal Cancer, Head and Neck Cancer, Liver Cancer, Breast Cancer, Prostate Cancer, Oligometastasis
- Being tested
- Radiotherapy on the MR-Linac, Imaging on the MR Linac
- Keywords
- Radiotherapy, Adaptive Radiotherapy
- Medical subject headings
- Rectal Neoplasms, Head and Neck Neoplasms, Liver Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy on the MR-LinacRadiation
Radiotherapy is performed on the 1.5 T MR Linac
Imaging on the MR LinacDiagnostic test
Only imaging performed on the MR Linac
| Study group | Role | What they receive |
|---|---|---|
| Rectal and anal cancer | Experimental | In this arm patients with rectal and anal cancer are recruited. Receives: Radiation: Radiotherapy on the MR-Linac |
| Prostate cancer | Experimental | In this arm patients with prostate cancer are recruited. Receives: Radiation: Radiotherapy on the MR-Linac |
| Head and neck cancer | Experimental | In this arm patients with head and neck cancers are recruited. Receives: Radiation: Radiotherapy on the MR-Linac |
| Esophageal cancer | Experimental | In this arm patients with esophageal cancer are recruited. Receives: Radiation: Radiotherapy on the MR-Linac |
| Breast Cancer | Experimental | In this arm patients with breast cancer are recruited. Receives: Radiation: Radiotherapy on the MR-Linac |
| Central nervous system tutors | Experimental | In this arm patients with tumors of the central nervous system are recruited. Receives: Radiation: Radiotherapy on the MR-Linac |
| Palliative treatments | Experimental | In this arm patients with palliative treatments are recruited. Receives: Radiation: Radiotherapy on the MR-Linac |
| Other | Experimental | In this arm patients with other tumors are recruited. Receives: Radiation: Radiotherapy on the MR-Linac |
| Imaging only | Experimental | In this arm patients receive only imaging on the MR-Linac Receives: Diagnostic Test: Imaging on the MR Linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of online MR guided Radiotherapy
Treatment of a patient is considered feasible when 85% of treatments were completed as planned in this patient
Measured: 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
Measured: During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start9 May 2018
- Primary completion9 May 2022 (estimated)
- Study completion9 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cihan Gani, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172753
- Sponsor's protocol ID
- 659/2017BO1
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 39881423Potkrajcic 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Imaging and Radiotherapy on a Novel 1.5 T Hybrid Magnetic Resonance Imaging - Linear Accelerator System (MR-Linac)
- ClinicalTrials.gov ID
- NCT04172753
- Acronym / sponsor ID
- 659/2017BO1
- Conditions
- Rectal Cancer, Head and Neck Cancer, Liver Cancer, Breast Cancer, Prostate Cancer, Oligometastasis
- Keywords
- Radiotherapy, Adaptive Radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 9 May 2022 (estimated)
- Study completion
- 9 May 2027 (estimated)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Rectal and anal cancer | Experimental | Radiation: Radiotherapy on the MR-LinacIn this arm patients with rectal and anal cancer are recruited. |
| Prostate cancer | Experimental | Radiation: Radiotherapy on the MR-LinacIn this arm patients with prostate cancer are recruited. |
| Head and neck cancer | Experimental | Radiation: Radiotherapy on the MR-LinacIn this arm patients with head and neck cancers are recruited. |
| Esophageal cancer | Experimental | Radiation: Radiotherapy on the MR-LinacIn this arm patients with esophageal cancer are recruited. |
| Breast Cancer | Experimental | Radiation: Radiotherapy on the MR-LinacIn this arm patients with breast cancer are recruited. |
| Central nervous system tutors | Experimental | Radiation: Radiotherapy on the MR-LinacIn this arm patients with tumors of the central nervous system are recruited. |
| Palliative treatments | Experimental | Radiation: Radiotherapy on the MR-LinacIn this arm patients with palliative treatments are recruited. |
| Other | Experimental | Radiation: Radiotherapy on the MR-LinacIn this arm patients with other tumors are recruited. |
| Imaging only | Experimental | Diagnostic Test: Imaging on the MR LinacIn this arm patients receive only imaging on the MR-Linac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- existing indication for radiation therapy
- minimum age 18 years, no upper age limit
- capacity for consent
- Informed consent
Key exclusion criteria (2 listed)
- contraindication for MRI (claustrophobia, metallic implants not applicable for MRI
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy on the MR-LinacRadiotherapy is performed on the 1.5 T MR Linac | Radiation | Breast Cancer, Central nervous system tutors, Esophageal cancer, Head and neck cancer, Other, Palliative treatments, Prostate cancer, Rectal and anal cancer |
| Imaging on the MR LinacOnly imaging performed on the MR Linac | Diagnostic test | Imaging only |
Primary outcome
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)
Treatment of a patient is considered feasible when 85% of treatments were completed as planned in this patient
1 secondary outcome
Time analysis
Time frame: During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Derived from this study: PubMed 39881423Boeke 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.
- Derived from this study: PubMed 38785484Potkrajcic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University Hospital Tübingen, Department of Radiation Oncology
Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy on the MR-Linac and Imaging on the MR Linac in people with Rectal Cancer and Head and Neck Cancer, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04172753, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.