JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Noch nicht rekrutierend

NCT-Nummer:
NCT06106997

Studienbeginn:
Januar 2024

Letztes Update:
30.10.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Erlangen-Nürnberg Medical School

Collaborator:
-

Studienleiter

Christoph Bert, Prof. Dr. rer. nat
Principal Investigator
Universitätsklinikum Erlangen, Strahlenklinik

Florian Putz, PD Dr. med.
Principal Investigator
Universitätsklinikum Erlangen, Strahlenklinik

Kontakt

Christoph Bert, Prof. Dr. rer. nat
Kontakt:
Phone: ++49(0)9131-85-44213
E-Mail: christoph.bert@uk-erlangen.de» Kontaktdaten anzeigen

Florian Putz, PD Dr. med.
Kontakt:
Phone: ++49(0)9131-85-33405
E-Mail: florian.putz@uk-erlangen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Erlangen, Universitätsklinikum Strahlenklinik
91054 Erlangen
(Bayern)
Germany» Google-Maps

Studien-Informationen

Detailed 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Proportion of patients that can successfully be treated in an MRI-only workflow (Time Frame - 12 month):
All criteria have to be met for the MRI-only workflow to be classified as successful: Verification criteria that will be assessed: Can the sCT be generated and is the sCT clinically utilizable? Are the three rotations needed for CT-MRI registration each ≤ 3°? Can a treatment plan be generated and verified using the sCT? Is the dosimetric difference between sCT and CT based treatment plan in the planning target volume ≤ 3%? Is the dosimetric difference between the sCT and CT based treatment plan in affected organs at risk (receiving > 10% of prescribed dose) ≤ 3%? Are the couch correction parameters during patient positioning in the rotational degrees of freedom ≤ 3°?

Secondary outcome:

1. Reasons that lead to unfeasibility of an MRI-only workflow (Time Frame - 12 month):
Presence (Yes/No) of individual reasons responsible for the unfeasibility of the MRI-only workflow, as assessed with a predefined checklist.

2. Dosimetric differences between MRI-only and standard workflow for radiotherapy treatment planning (Time Frame - 12 month):
Paired difference in Dose-volume-histogram parameters (Target coverage, mean, median, near maximum and minimum dose) between MRI-only and standard radiotherapy treatment workflow.

3. Measurement of intra-MRI patient positional changes (Time Frame - 12 month):
Patient shift (vector magnitude) and rotational errors occuring during the course of MRI acquisition due to patient movement, as assessed by rigid registration of the last acquired MRI sequence in reference to the first sequence.

4. Organ at risk contouring accuracy on MRI data (Time Frame - 12 month):
Similarity of organ at risk segmentations defined in MRI compared to reference segmentations defined in CT as assessed by the volumetric and surface Dice score, as well as mean surface and Hausdorff distances.

Geprüfte Regime

brain radiotherapy:
brain radiotherapy planned on synthetic CTs

Quelle: ClinicalTrials.gov

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