659/2017BO1Recruiting

Feasibility Study on Magnetic Resonance Imaging-Guided Radiation Therapy Using an MR-Linac

Gender
Women and men
Age
18 years and older
Trial type
Interventional
Line of therapy
all
Phase

What is this trial about?

Radiation therapy using the MR-Linac is used when tumors need to be treated with particularly high precision while minimizing damage to the surrounding healthy tissue as much as possible. The aim of this study is to determine whether a novel combination of magnetic resonance imaging and radiation therapy—the so-called MR-Linac—can be reliably used in everyday clinical practice. Adult patients for whom radiation therapy is medically necessary and who have no contraindications to an MRI scan are eligible to participate.

Trial flow

Requirements

Diagnosis: Rectal Cancer; Head and Neck Cancer; Liver Cancer; Breast Cancer; Prostate Cancer; Oligometastasis; Esophageal Cancer

Age: 18–99 years

Line of therapy: Unabhängig von Therapielinie

Key inclusion criteria: Existing indication for radiation therapy

Allocation

Einarmigen Studie

Treatment

approx. 1 weeks
Radiotherapy using MR-LinacTreatment of a patient is considered feasible when 85 % of treatments were completed as planned

Follow-up

Detailed description

The current standard treatment for many types of cancer consists of conventional radiation therapy, for which computed tomography (CT) is usually used for planning. However, the image quality of CT is inferior to that of magnetic resonance imaging (MRI), especially when it comes to soft tissue. The MR-Linac system could significantly improve the precision of treatment. It combines two devices: an MRI scanner for high-resolution imaging and a linear accelerator for irradiating tumors. What makes this system unique is that precise images of the tumor can be taken immediately before and during radiation therapy. This allows the radiation to be adjusted very precisely, which could better spare the surrounding healthy tissue and reduce side effects.

The goal of this study is to investigate whether treatment using MR-Linac can be reliably implemented in everyday clinical practice (feasibility study). The study will assess whether at least 85% of the planned treatments, lasting 1 to 7 weeks, can be carried out. All patients will receive treatment with MR-Linac as part of the study. There is no follow-up observation.

Eligible participants include women and men aged 18 and older with various types of tumors, such as prostate cancer, breast cancer, rectal or esophageal cancer, head and neck tumors, liver tumors, or brain tumors. Patients who require palliative radiation therapy (which is not intended to cure the disease) may also participate. Treatment is provided exclusively using the new MR-Linac device at the University Hospital of Tübingen. Individuals with contraindications for an MRI (e.g., severe claustrophobia or certain metal implants) as well as pregnant women are excluded.

Facts

  1. Which diseases: Prostate, breast, rectal, esophageal, head and neck, liver, and CNS tumors, as well as a few metastases (oligometastases) and symptom-oriented (palliative) indications
  2. Cancer characteristics: Patients scheduled for radiation therapy, regardless of prior treatment
  3. What the study investigates: Feasibility of treatment using the MR-Linac device
  4. Study objective: To determine whether at least 85% of treatments can be performed as planned
  5. How long will the study last: through 2027; individual treatment duration 1–7 weeks
  6. Study characteristics: one group, open-label, single-center study at the University Hospital of Tübingen

Trial sites

1 trial site in Germany is listed.

  • Universitätsklinikum Tübingen

    Geissweg 3, 72076 Tübingen

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT04172753) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.