Clinical trial · Interventional
Clinical Feasibility of Brain Radiotherapy Using Synthetic CTs in an MRI-only Workflow
Feasibility Study of an MRI-only Workflow: Use of Synthetic CTs Generated From MRI Data for MRI-based Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor - Metastatic | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brain radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- sCT workflow
- description
- sCT workflow
- interventionNames
- Radiation: brain radiotherapy
Primary outcomes (1)
- measure
- Proportion of patients that can successfully be treated in an MRI-only workflow
- timeFrame
- 12 month
- description
- All criteria have to be met for the MRI-only workflow to be classified as successful: Verification criteria that will be assessed: 1. Can the sCT be generated and is the sCT clinically utilizable? 2. Are the three rotations needed for CT-MRI registration each ≤ 3°? 3. Can a treatment plan be generated and verified using the sCT? 4. Is the dosimetric difference between sCT and CT based treatment plan in the planning target volume ≤ 3%? 5. Is the dosimetric difference between the sCT and CT based treatment plan in affected organs at risk (receiving \> 10% of prescribed dose) ≤ 3%? 6. Are the couch correction parameters during patient positioning in the rotational degrees of freedom ≤ 3°?
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGrigo J, Szkitsak J, Hofler D, Fietkau R, Putz F, Bert C. "sCT-Feasibility" - a feasibility study for deep learning-based MRI-only brain radiotherapy. Radiat Oncol. 2024 Mar 8;19(1):33. doi: 10.1186/s13014-024-02428-3. PMID 38459584