Clinical Feasibility of Brain Radiotherapy Using Synthetic CTs in an MRI-only Workflow

University of Erlangen-Nürnberg Medical School

Status

Not yet enrolling

Conditions

Brain Tumor, Primary

Brain Tumor - Metastatic

Treatments

Radiation: brain radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06106997

sCT-Feasibility

Details and patient eligibility

About

The goal of this observational study is to show the feasibility of an MRI-only workflow in brain radiotherapy. The main question it aims to answer is:

Is an MRI-only workflow based on deep learning sCTs feasible in clinical routine? Participants will be treated as in clinical routine, but treatment planning will be based on sCTs, that are generated from MRI images. The dosimetrical equivalence to the standard CT based workflow will be tested at several points in the study.

Full description

The purpose of this clinical study is to investigate the clinical feasibility of a deep learning-based MRI-only workflow for brain radiotherapy, that eliminates the registration uncertainty through calculation of a synthetic CT (sCT) from MRI data.

A total of 54 patients with an indication for radiation treatment of the brain and stereotactic mask immobilization will be recruited. All study patients will receive standard therapy and imaging including both CT and MRI. All patients will receive dedicated RT-MRI scans in treatment position. An sCT will be reconstructed from an acquired MRI DIXON-sequence using a commercially available deep learning solution on which subsequent radiotherapy planning will be performed. Through multiple quality assurance (QA) measures and reviews during the course of the study, the feasibility of an MRI-only workflow and comparative parameters between sCT and standard CT workflow will be investigated holistically. These QA measures include feasibility and quality of image guidance (IGRT) at the linear accelerator using sCT derived digitally reconstructed radiographs in addition to potential dosimetric deviations between the CT and sCT plan. The aim of this clinical study is to establish a brain MRI-only workflow as well as to identify risks and QA mechanisms to ensure a safe integration of deep learning-based sCT into radiotherapy planning and delivery.

Enrollment

54 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent
Patient older than 18 years
Tumor or metastases in the brain
Immobilization with stereotactic mask
Treatment on stereotactic linear accelerator (2.5 mm leafs) equipped with 2D/2D X-ray system

Exclusion criteria

Metal in the body, metal implants, pacemakers or other patient-specific factors that are a contraindication to an MRI scan
Metal implants, pacemakers or other patient-specific factors associated with increased risk from an MRI scan
Renal insufficiency (eGFR < 60 ml/min), allergy or other patient-specific factors that constitute a contraindication to contrast administration
Renal insufficiency (eGFR < 60 ml/min), allergy or other patient-specific factors associated with an increased risk from contrast administration
Patients who are institutionalized in care facilities, prisons or other supervised facilities.
Patients under guardianship
Non-consenting patients
Pregnant or breastfeeding patients