The MR-Linac Technical Feasibility Protocol

NCT04351204 | Recruiting

• 2 other identifiers: N18BRELNL 65953.031.18
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumors at All Sites Which Will Receive Radiotherapy

Keywords

radiotherapy; MR Linac

Outcome Measures

Primary Outcomes (1)

• technical feasibility

  Feasibility of the technical procedure is demonstrated if the technique is successfully applied in 9 out of 10 consecutive patients

  4 years

Study Arms (1)

MRL

OTHER

radiotherapy on MR linac

Radiation: radiotherapy

Interventions

radiotherapy RADIATION

multiple new techniques and software for MR-guided adaptive radiation therapy.

Also known as: MR Linac

MRL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Elekta Limited: collaborator

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, 1066CX, Netherlands

RECRUITING

Related Publications (5)

• 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.

  PMID: 22177878 RESULT

• 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 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.

  PMID: 23664076 RESULT

• 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 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.

  PMID: 26678659 RESULT

• 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. Radiother Oncol. 2016 Jun;119(3):371-80. doi: 10.1016/j.radonc.2016.04.014. Epub 2016 May 6.

  PMID: 27162159 RESULT

• 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(1):154-9. doi: 10.1016/j.radonc.2015.11.003. Epub 2015 Nov 26.

  PMID: 26631646 RESULT

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Marlies Nowee, MD, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlies Nowee, MD, PhD

CONTACT

+31 20 512 9111; m.nowee@nki.nl

Uulke vd Heide, PhD

CONTACT

+31 20 512 9111; u.vd.heide@nki.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 17, 2020
• Study Start: January 22, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)