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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04172753
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Cihan Gani, University Hospital Tuebingen

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

Condition or disease Intervention/treatment Phase
Rectal Cancer Head and Neck Cancer Liver Cancer Breast Cancer Prostate Cancer Oligometastasis Esophageal Cancer Radiation: Radiotherapy on the MR-Linac Diagnostic Test: Imaging on the MR Linac Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 472 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Imaging and Radiotherapy on a Novel 1.5 T Hybrid Magnetic Resonance Imaging - Linear Accelerator System (MR-Linac)
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : May 9, 2022
Estimated Study Completion Date : May 9, 2027

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04172753


Locations
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Germany
University Hospital Tübingen, Department of Radiation Oncology Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Daniel Zips, MD, Prof    +49 (0) 7071 29-85990    ro-info@med.uni-tuebingen.de   
Contact: Cihan Gani, MD    +49 (0)7071 29-82165    cihan.gani@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen

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Responsible Party: Dr. Cihan Gani, Lead of gastrointestinal radiation oncology, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04172753    
Other Study ID Numbers: 659/2017BO1
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Cihan Gani, University Hospital Tuebingen:
Radiotherapy
Adaptive Radiotherapy