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

Not Applicable

Recruiting

• Conditions: Rectal Cancer; Head and Neck Cancer; Liver Cancer; Breast Cancer; Esophageal Cancer; Prostate Cancer; Oligometastasis
• Interventions: Radiation: Radiotherapy on the MR-Linac; Diagnostic Test: Imaging on the MR Linac

• Registration Number: NCT04172753
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-05-09
• Status Verified: 2019-11
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-19
• Last Update Submitted: 2019-11-19
• Study First Posted: 2019-11-21
• Last Update Posted: 2019-11-21
• Primary Completion: 2022-05-09
• Study Completion: 2027-05-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 472

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Other	Radiotherapy on the MR-Linac	In this arm patients with other tumors are recruited.
Head and neck cancer	Radiotherapy on the MR-Linac	In this arm patients with head and neck cancers are recruited.
Breast Cancer	Radiotherapy on the MR-Linac	In this arm patients with breast cancer are recruited.
Rectal and anal cancer	Radiotherapy on the MR-Linac	In this arm patients with rectal and anal cancer are recruited.
Prostate cancer	Radiotherapy on the MR-Linac	In this arm patients with prostate cancer are recruited.
Esophageal cancer	Radiotherapy on the MR-Linac	In this arm patients with esophageal cancer are recruited.
Imaging only	Imaging on the MR Linac	In this arm patients receive only imaging on the MR-Linac
Central nervous system tutors	Radiotherapy on the MR-Linac	In this arm patients with tumors of the central nervous system are recruited.
Palliative treatments	Radiotherapy on the MR-Linac	In this arm patients with palliative treatments are recruited.

Primary Outcome Measures

Name	Time	Method
Feasibility of online MR guided Radiotherapy	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

Name	Time	Method
Time analysis	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

Trial Locations

Locations (1)

University Hospital Tübingen, Department of Radiation Oncology; 🇩🇪 Tübingen, Baden-Württemberg, Germany