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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04172753
• Other study ID #: 659/2017BO1
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: May 9, 2027

Study information

• Verified date: November 2019
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 472
• Est. completion date: May 9, 2027
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Esophageal Cancer
• Head and Neck Cancer
• Liver Cancer
• Oligometastasis
• Prostate Cancer
• Rectal Cancer

Intervention

Radiation:
• Radiotherapy on the MR-Linac
Radiotherapy is performed on the 1.5 T MR Linac

Diagnostic Test:
• Imaging on the MR Linac
Only imaging performed on the MR Linac

Locations

Country	Name	City	State
Germany	University Hospital Tübingen, Department of Radiation Oncology	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of online MR guided 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	Time analysis	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)