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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06106997
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Erlangen-Nürnberg Medical School
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Christoph Bert, Prof. Dr. rer. natFlorian Putz, PD Dr. med.
Principal Investigator Affiliation Universitätsklinikum Erlangen, StrahlenklinikUniversitätsklinikum Erlangen, Strahlenklinik
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain Tumor, Primary, Brain Tumor - Metastatic
Additional Details

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.

Arms & Interventions

Arms

Other: sCT workflow

sCT workflow

Interventions

Radiation: - brain radiotherapy

brain radiotherapy planned on synthetic CTs

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Erlangen, Germany

Status

Address

Erlangen, Universitätsklinikum Strahlenklinik

Erlangen, , 91054

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