Tumors at All Sites Which Will Receive RadiotherapyUMBRELLA-IINCT04351204
The MR-Linac Technical Feasibility Protocol
A study testing radiotherapy in people with Tumors at All Sites Which Will Receive Radiotherapy, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
Radiation therapy is predominantly based on a Computed Tomography (CT) scan obtained during the treatment planning phase. During the course of radiotherapy, however, both the tumor and organs at risk (OAR) are variable in position, shape and size between fractions, and during beam delivery within one treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors at All Sites Which Will Receive Radiotherapy
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jan 2019to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient, age ≥ 18 years, treated with radiation therapy on the MRL.
- WHO performance 0-2.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Contra-indications for an MRI examination.
- Patient is pregnant.
- Claustrophobia.
- Patients >140 kg and/or a body width > 60 cm.
- Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements or severe psychiatric illness/social situation.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Netherlands Cancer Institute
Amsterdam, 1066CX
Marlies Nowee, MD, PhD, +31 20 512 9111, m.nowee@nki.nl
Uulke vd Heide, PhD, +31 20 512 9111, u.vd.heide@nki.nl
About this study
Official title: The MR-Linac Technical Feasibility Protocol For Development of MR-guided Adaptive RadiationTherapy
Radiation therapy is predominantly based on a Computed Tomography (CT) scan obtained during the treatment planning phase. During the course of radiotherapy, however, both the tumor and organs at risk (OAR) are variable in position, shape and size between fractions, and during beam delivery within one treatment fraction. Around the clinical target volume (CTV) a safety margin (Planning Target Volume, PTV) is created to account for these geometric uncertainties to ensure that the tumor receives the prescribed dose.
Direct integration of imaging at the linear accelerator enables daily monitoring of patient positioning, tumor position, and alterations in patient anatomy. Image guided radiotherapy (IGRT) enables the detection and immediate correction of such deviations and increases the precision of delivery.
Read more
Adaptive radiotherapy has become an important strategy for serially modifying dose distributions in a manner that can substantially reduce OAR dose and subsequent toxicity, while maintaining adequate target coverage. Current adaptive protocols rely upon a standard CT-based workflow and (cone-beam) CT-based image guidance.
Magnetic Resonance Imaging (MRI) has superior soft-tissue contrast over CT and seems a very promising modality to integrate in the radiation treatment process, facilitating better visualization of the tumor and OAR during treatment.
Read the detailed description
The proposed protocol aims to determine feasibility of multiple new techniques and software for MR-guided adaptive radiation therapy. For each proposed technique feasibility has to be determined individually. A secondary aim is to prospectively collect data from cohorts of patients treated at the MRL and report on acute toxicity.
By including multiple parallel cohorts, the protocol will accelerate the technical development of MR-guided adaptive radiotherapy and the evidence-based introduction of the MRL into clinical practice.
- Being tested
- radiotherapy
- Keywords
- radiotherapy, MR Linac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
Also called MR Linac
multiple new techniques and software for MR-guided adaptive radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| MRL | Other | radiotherapy on MR linac Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical feasibility
Feasibility of the technical procedure is demonstrated if the technique is successfully applied in 9 out of 10 consecutive patients
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start22 Jan 2019
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tumors at All Sites Which Will Receive RadiotherapyStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Elekta Limited
- Responsible party
- Sponsor
- Investigators
- Marlies Nowee, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351204
- Sponsor's protocol ID
- N18BREL
- Other IDs
- NL 65953.031.18
- Acronym
- UMBRELLA-II
- Status last verified
- Jan 2024
- First submitted
- 15 Apr 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bujold A, Craig T, Jaffray D, Dawson LA. Image-guided radiotherapy: has it influenced patient outcomes? Semin Radiat Oncol. 2012 Jan;22(1):50-61. doi: 10.1016/j.semradonc.2011.09.001.
PubMed 22177878De Los Santos J, Popple R, Agazaryan N, Bayouth JE, Bissonnette JP, Bucci MK, Dieterich S, Dong L, Forster KM, Indelicato D, Langen K, Lehmann J, Mayr N, Parsai I, Salter W, Tomblyn M, Yuh WT, Chetty IJ. Image guided radiation therapy (IGRT) technologies for radiation therapy localization and delivery. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):33-45. doi: 10.1016/j.ijrobp.2013.02.021. Epub 2013 May 7. No abstract available.
PubMed 23664076Acharya S, Fischer-Valuck BW, Kashani R, Parikh P, Yang D, Zhao T, Green O, Wooten O, Li HH, Hu Y, Rodriguez V, Olsen L, Robinson C, Michalski J, Mutic S, Olsen J. Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):394-403. doi: 10.1016/j.ijrobp.2015.10.015. Epub 2015 Oct 17.
PubMed 26678659McPartlin AJ, Li XA, Kershaw LE, Heide U, Kerkmeijer L, Lawton C, Mahmood U, Pos F, van As N, van Herk M, Vesprini D, van der Voort van Zyp J, Tree A, Choudhury A; MR-Linac consortium. MRI-guided prostate adaptive radiotherapy - A systematic review. Radiother Oncol. 2016 Jun;119(3):371-80. doi: 10.1016/j.radonc.2016.04.014. Epub 2016 May 6.
PubMed 27162159Vestergaard A, Hafeez S, Muren LP, Nill S, Hoyer M, Hansen VN, Gronborg C, Pedersen EM, Petersen JB, Huddart R, Oelfke U. The potential of MRI-guided online adaptive re-optimisation in radiotherapy of urinary bladder cancer. Radiother Oncol. 2016 Jan;118(1):154-9. doi: 10.1016/j.radonc.2015.11.003. Epub 2015 Nov 26.
PubMed 26631646
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MR-Linac Technical Feasibility Protocol For Development of MR-guided Adaptive RadiationTherapy
- ClinicalTrials.gov ID
- NCT04351204
- Acronym / sponsor ID
- UMBRELLA-II / N18BREL
- Keywords
- radiotherapy, MR Linac
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Elekta Limited
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 17 Apr 2020 (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.
Radiation therapy is predominantly based on a Computed Tomography (CT) scan obtained during the treatment planning phase. During the course of radiotherapy, however, both the tumor and organs at risk (OAR) are variable in position, shape and size between fractions, and during beam delivery within one treatment fraction. Around the clinical target volume (CTV) a safety margin (Planning Target Volume, PTV) is created to account for these geometric uncertainties to ensure that the tumor receives the prescribed dose.
Direct integration of imaging at the linear accelerator enables daily monitoring of patient positioning, tumor position, and alterations in patient anatomy. Image guided radiotherapy (IGRT) enables the detection and immediate correction of such deviations and increases the precision of delivery.
Adaptive radiotherapy has become an important strategy for serially modifying dose distributions in a manner that can substantially reduce OAR dose and subsequent toxicity, while maintaining adequate target coverage. Current adaptive protocols rely upon a standard CT-based workflow and (cone-beam) CT-based image guidance.
Magnetic Resonance Imaging (MRI) has superior soft-tissue contrast over CT and seems a very promising modality to integrate in the radiation treatment process, facilitating better visualization of the tumor and OAR during treatment.
Detailed description
The proposed protocol aims to determine feasibility of multiple new techniques and software for MR-guided adaptive radiation therapy. For each proposed technique feasibility has to be determined individually. A secondary aim is to prospectively collect data from cohorts of patients treated at the MRL and report on acute toxicity.
By including multiple parallel cohorts, the protocol will accelerate the technical development of MR-guided adaptive radiotherapy and the evidence-based introduction of the MRL into clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRL | Other | Radiation: radiotherapyradiotherapy on MR linac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient, age ≥ 18 years, treated with radiation therapy on the MRL.
- WHO performance 0-2.
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (5 listed)
- Contra-indications for an MRI examination.
- Patient is pregnant.
- Claustrophobia.
- Patients >140 kg and/or a body width > 60 cm.
- Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements or severe psychiatric illness/social situation.
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 |
|---|---|---|
| radiotherapyAlso: MR Linacmultiple new techniques and software for MR-guided adaptive radiation therapy. | Radiation | MRL |
Primary outcome
technical feasibility
Time frame: 4 years
Feasibility of the technical procedure is demonstrated if the technique is successfully applied in 9 out of 10 consecutive patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Results publication: PubMed 22177878Bujold A, Craig T, Jaffray D, Dawson LA. Image-guided radiotherapy: has it influenced patient outcomes? Semin Radiat Oncol. 2012 Jan;22(1):50-61. doi: 10.1016/j.semradonc.2011.09.001.
- Results publication: PubMed 23664076De Los Santos J, Popple R, Agazaryan N, Bayouth JE, Bissonnette JP, Bucci MK, Dieterich S, Dong L, Forster KM, Indelicato D, Langen K, Lehmann J, Mayr N, Parsai I, Salter W, Tomblyn M, Yuh WT, Chetty IJ. Image guided radiation therapy (IGRT) technologies for radiation therapy localization and delivery. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):33-45. doi: 10.1016/j.ijrobp.2013.02.021. Epub 2013 May 7. No abstract available.
- Results publication: PubMed 26678659Acharya S, Fischer-Valuck BW, Kashani R, Parikh P, Yang D, Zhao T, Green O, Wooten O, Li HH, Hu Y, Rodriguez V, Olsen L, Robinson C, Michalski J, Mutic S, Olsen J. Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):394-403. doi: 10.1016/j.ijrobp.2015.10.015. Epub 2015 Oct 17.
- Results publication: PubMed 27162159McPartlin AJ, Li XA, Kershaw LE, Heide U, Kerkmeijer L, Lawton C, Mahmood U, Pos F, van As N, van Herk M, Vesprini D, van der Voort van Zyp J, Tree A, Choudhury A; MR-Linac consortium. MRI-guided prostate adaptive radiotherapy - A systematic review. Radiother Oncol. 2016 Jun;119(3):371-80. doi: 10.1016/j.radonc.2016.04.014. Epub 2016 May 6.
- Results publication: PubMed 26631646Vestergaard A, Hafeez S, Muren LP, Nill S, Hoyer M, Hansen VN, Gronborg C, Pedersen EM, Petersen JB, Huddart R, Oelfke U. The potential of MRI-guided online adaptive re-optimisation in radiotherapy of urinary bladder cancer. Radiother Oncol. 2016 Jan;118(1):154-9. doi: 10.1016/j.radonc.2015.11.003. Epub 2015 Nov 26.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Marlies Nowee, MD, PhD principal investigator
The Netherlands Cancer Institute
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 in people with Tumors at All Sites Which Will Receive Radiotherapy, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlies Nowee, MD, PhD (+31 20 512 9111, m.nowee@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical feasibility (time frame: 4 years). 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 NCT04351204, which also lists 5 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 1 Feb 2024.