Feasibility of Online MR-guided Radiotherapy on a 1.5T MR-Linac

November 19, 2019 updated by: Dr. Cihan Gani, University Hospital Tuebingen

Feasibility of Imaging and Radiotherapy on a Novel 1.5 T Hybrid Magnetic Resonance Imaging - Linear Accelerator System (MR-Linac)

This study investigates the feasibility of imaging and treatment on a novel 1.5 T MR-Linac radiotherapy hybrid device.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Novel hybrid devices combine magnetic resonance imaging (MRI) and a linear accelerator in a single device. The superior soft tissue contrast compared with cone-beam computed tomography based treatment and the possibility for daily plan adaptation promise a higher precision of treatment, better target volume coverage and normal tissue sparing. In a first step the present study will test the feasibility of imaging and treatment on the 1.5 T MR-Linac.

Study Type

Interventional

Enrollment (Anticipated)

472

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 Locations

  • Germany
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • existing indication for radiation therapy
  • minimum age 18 years, no upper age limit
  • capacity for consent
  • Informed consent

Exclusion Criteria:

  • contraindication for MRI (claustrophobia, metallic implants not applicable for MRI
  • pregnancy

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rectal and anal cancer
In this arm patients with rectal and anal cancer are recruited.
Radiation: Radiotherapy on the MR-Linac
Radiotherapy is performed on the 1.5 T MR Linac
Experimental: Prostate cancer
In this arm patients with prostate cancer are recruited.
Radiation: Radiotherapy on the MR-Linac
Radiotherapy is performed on the 1.5 T MR Linac
Experimental: Head and neck cancer
In this arm patients with head and neck cancers are recruited.
Radiation: Radiotherapy on the MR-Linac
Radiotherapy is performed on the 1.5 T MR Linac
Experimental: Esophageal cancer
In this arm patients with esophageal cancer are recruited.
Radiation: Radiotherapy on the MR-Linac
Radiotherapy is performed on the 1.5 T MR Linac
Experimental: Breast Cancer
In this arm patients with breast cancer are recruited.
Radiation: Radiotherapy on the MR-Linac
Radiotherapy is performed on the 1.5 T MR Linac
Experimental: Central nervous system tutors
In this arm patients with tumors of the central nervous system are recruited.
Radiation: Radiotherapy on the MR-Linac
Radiotherapy is performed on the 1.5 T MR Linac
Experimental: Palliative treatments
In this arm patients with palliative treatments are recruited.
Radiation: Radiotherapy on the MR-Linac
Radiotherapy is performed on the 1.5 T MR Linac
Experimental: Other
In this arm patients with other tumors are recruited.
Radiation: Radiotherapy on the MR-Linac
Radiotherapy is performed on the 1.5 T MR Linac
Experimental: Imaging only
In this arm patients receive only imaging on the MR-Linac
Diagnostic test: Imaging on the MR Linac
Only imaging performed on the MR Linac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of online MR guided Radiotherapy
Time Frame: During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)
Treatment of a patient is considered feasible when 85% of treatments were completed as planned in this patient
During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time analysis
Time Frame: During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)
Time required for online MR guided radiotherapy
During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)

Collaborators and Investigators

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

Sponsor

University Hospital Tuebingen

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)

May 9, 2018

Primary Completion (Anticipated)

May 9, 2022

Study Completion (Anticipated)

May 9, 2027

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 19, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 659/2017BO1

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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