NCT04351204 The MR-Linac Technical Feasibility Protocol
| NCT ID | NCT04351204 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Netherlands Cancer Institute |
| Condition | Tumors at All Sites Which Will Receive Radiotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2019-01-22 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2019-01-22 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Marlies Nowee, MD, PhD
PRINCIPAL INVESTIGATOR
The Netherlands Cancer Institute
Frequently Asked Questions
Who can join the NCT04351204 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tumors at All Sites Which Will Receive Radiotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04351204 currently recruiting?
Yes, NCT04351204 is actively recruiting participants. Contact the research team at m.nowee@nki.nl for enrollment information.
Where is the NCT04351204 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT04351204 clinical trial?
NCT04351204 is sponsored by The Netherlands Cancer Institute. The principal investigator is Marlies Nowee, MD, PhD at The Netherlands Cancer Institute. The trial plans to enroll 140 participants.