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

NCT06106997 | Unknown

• 1 other identifier: sCT-Feasibility
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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 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

Brain Tumor, Primary; Brain Tumor - Metastatic

Outcome Measures

Primary Outcomes (1)

• 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: 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°?

  12 month

Secondary Outcomes (4)

• Reasons that lead to unfeasibility of an MRI-only workflow

  12 month

• Dosimetric differences between MRI-only and standard workflow for radiotherapy treatment planning

  12 month

• Measurement of intra-MRI patient positional changes

  12 month

• Organ at risk contouring accuracy on MRI data

  12 month

Study Arms (1)

sCT workflow

OTHER

sCT workflow

Radiation: brain radiotherapy

Interventions

brain radiotherapy RADIATION

brain radiotherapy planned on synthetic CTs

sCT workflow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Erlangen, Universitätsklinikum Strahlenklinik

Erlangen, 91054, Germany

Location

Related Publications (1)

• 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.

  PMID: 38459584 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Christoph Bert, Prof. Dr. rer. nat

  Universitätsklinikum Erlangen, Strahlenklinik

  PRINCIPAL INVESTIGATOR

• Florian Putz, PD Dr. med.

  Universitätsklinikum Erlangen, Strahlenklinik

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Bert, Prof. Dr. rer. nat

CONTACT

++49(0)9131-85-44213; christoph.bert@uk-erlangen.de

Florian Putz, PD Dr. med.

CONTACT

++49(0)9131-85-33405; florian.putz@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 30, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: August 1, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

DE (1)