The MR-Linac Technical Feasibility Protocol

Tumors at All Sites Which Will Receive Radiotherapy Clinical Trial

— UMBRELLA-II  

Official title:

The MR-Linac Technical Feasibility Protocol For Development of MR-guided Adaptive RadiationTherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04351204
• Other study ID #: N18BREL
• Secondary ID: NL 65953.031.18
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2019
• Est. completion date: July 1, 2026

Study information

• Verified date: January 2024
• Source: The Netherlands Cancer Institute
• Contact: Marlies Nowee, MD, PhD
• Phone: +31 20 512 9111
• Email: m.nowee[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tumors at All Sites Which Will Receive Radiotherapy

Intervention

Radiation:
• radiotherapy
multiple new techniques and software for MR-guided adaptive radiation therapy.

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Elekta Limited

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

Acharya 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 Applicati — View Citation

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. — View Citation

De 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 — View Citation

McPartlin 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. Radio — View Citation

Vestergaard 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	technical feasibility	Feasibility of the technical procedure is demonstrated if the technique is successfully applied in 9 out of 10 consecutive patients	4 years