Brain Tumor, PrimaryNCT06106997
Clinical Feasibility of Brain Radiotherapy Using Synthetic CTs in an MRI-only Workflow
A study testing brain radiotherapy in people with Brain Tumor, Primary and Brain Tumor - Metastatic, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Primary, Brain Tumor - Metastatic
- What is being tested?
- brain radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of an MRI-only Workflow: Use of Synthetic CTs Generated From MRI Data for MRI-based Radiotherapy
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.
Read the 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.
- Conditions
- Brain Tumor, Primary, Brain Tumor - Metastatic
- Being tested
- brain radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brain radiotherapyRadiation
brain radiotherapy planned on synthetic CTs
| Study group | Role | What they receive |
|---|---|---|
| sCT workflow | Other | sCT workflow Receives: Radiation: brain radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that can successfully be treated in an MRI-only workflow
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°?
Measured: 12 month
Secondary outcomes (4)
Reasons that lead to unfeasibility of an MRI-only workflow
Presence (Yes/No) of individual reasons responsible for the unfeasibility of the MRI-only workflow, as assessed with a predefined checklist.
Measured: 12 month
Dosimetric differences between MRI-only and standard workflow for radiotherapy treatment planning
Paired difference in Dose-volume-histogram parameters (Target coverage, mean, median, near maximum and minimum dose) between MRI-only and standard radiotherapy treatment workflow.
Measured: 12 month
Measurement of intra-MRI patient positional changes
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.
Measured: 12 month
Organ at risk contouring accuracy on MRI data
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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Tumor, PrimaryStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Bert, Prof. Dr. rer. nat, Principal investigator, Universitätsklinikum Erlangen, StrahlenklinikFlorian Putz, PD Dr. med., Principal investigator, Universitätsklinikum Erlangen, Strahlenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106997
- Sponsor's protocol ID
- sCT-Feasibility
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grigo 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.
PubMed 38459584
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an MRI-only Workflow: Use of Synthetic CTs Generated From MRI Data for MRI-based Radiotherapy
- ClinicalTrials.gov ID
- NCT06106997
- Acronym / sponsor ID
- sCT-Feasibility
- Conditions
- Brain Tumor, Primary, Brain Tumor - Metastatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sCT workflow | Other | Radiation: brain radiotherapysCT workflow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brain radiotherapybrain radiotherapy planned on synthetic CTs | Radiation | sCT workflow |
Primary outcome
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: 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°?
4 secondary outcomes
Reasons that lead to unfeasibility of an MRI-only workflow
Time frame: 12 month
Dosimetric differences between MRI-only and standard workflow for radiotherapy treatment planning
Time frame: 12 month
Measurement of intra-MRI patient positional changes
Time frame: 12 month
Organ at risk contouring accuracy on MRI data
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 38459584Grigo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Bert, Prof. Dr. rer. nat principal investigator
Universitätsklinikum Erlangen, Strahlenklinik
Florian Putz, PD Dr. med. principal investigator
Universitätsklinikum Erlangen, Strahlenklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brain radiotherapy in people with Brain Tumor, Primary and Brain Tumor - Metastatic, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Bert, Prof. Dr. rer. nat (++49(0)9131-85-44213, christoph.bert@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients that can successfully be treated in an MRI-only workflow (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06106997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.