Clinical Feasibility of Brain Radiotherapy Using Synthetic CTs in an

Status Not yet recruiting

Clinical 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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06106997
Study type	Interventional
Source	University of Erlangen-Nürnberg Medical School
Contact	Christoph Bert, Prof. Dr. rer. nat
Phone	++49(0)9131-85-44213
Email	christoph.bert@uk-erlangen.de
Status	Not yet recruiting
Phase	N/A
Start date	January 2024
Completion date	August 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06057168` - Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas	Phase 3
Recruiting	`NCT04427384` - Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
Completed	`NCT03323450` - Cognitive Remediation Therapy for Brain Tumor Patients: Improving Working Memory	N/A
Completed	`NCT00241670` - Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid	Phase 3
Not yet recruiting	`NCT01445691` - More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery	Phase 2
Completed	`NCT02599142` - Comparing Immobilisation Shells in Cranial Radiotherapy	N/A
Recruiting	`NCT06282562` - FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients	N/A
Completed	`NCT00001574` - A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors
Completed	`NCT04365647` - Intra-operative Variation in Size of Brain Tumors After Craniotomy
Withdrawn	`NCT04776980` - Multimodality MRI and Liquid Biopsy in GBM	Early Phase 1
Completed	`NCT03262636` - Two-Part Study to Evaluate the Safety and Efficacy of Image Guided Surgery Using Indocyanine Green for Intramolecular Imaging of Nervous System Tumors Compared to Standard of Care, (TumorGlow)	Phase 1
Active, not recruiting	`NCT02006407` - A Pilot Study to Evaluate Neurocognitive Injury and Longitudinal Changes in White Matter During Radiation Therapy in Children With Primary Brain Tumors	N/A
Recruiting	`NCT03213002` - Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM	Phase 1/Phase 2
Recruiting	`NCT05775458` - Glutamate Excitotoxicity and Its Role in Glioblastoma Biology
Terminated	`NCT04901806` - Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors	Phase 1
Recruiting	`NCT03373487` - Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery	N/A
Recruiting	`NCT05254197` - SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)
Recruiting	`NCT05092802` - The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment	Phase 2
Recruiting	`NCT05480644` - Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
Recruiting	`NCT05831631` - Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms