The MR-Linac Technical Feasibility Protocol (UMBRELLA-II)

January 31, 2024 updated by: The Netherlands Cancer Institute

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marlies Nowee, MD, PhD
  • Phone Number: +31 20 512 9111
  • Email: m.nowee@nki.nl

Study Contact Backup

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Recruiting
        • Netherlands Cancer Institute
        • Contact:
          • Marlies Nowee, MD, PhD
          • Phone Number: +31 20 512 9111
          • Email: m.nowee@nki.nl
        • Contact:
        • Principal Investigator:
          • Marlies Nowee, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MRL
radiotherapy on MR linac
Radiation: radiotherapy
multiple new techniques and software for MR-guided adaptive radiation therapy.
Other Names:
  • MR Linac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Collaborators

Elekta Limited

Investigators

  • Principal Investigator: Marlies Nowee, MD, PhD, the Netherlands Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2019

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • N18BREL
  • NL 65953.031.18 (Registry Identifier: Centrale Commissie Mensgebonden onderzoek)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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