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11C-methionine in the diagnostics and management of glioblastoma patients with rapid early progression: nonrandomized, open label, prospective clinical trial (GlioMET)
R. Lakomý, M. Lojová, L. Souckova, L. Hynkova, K. Polachova, J. Vasina, R. Demlová, A. Poprach, J. Sana, T. Prochazka, M. Smrcka, P. Fadrus, R. Jancalek, I. Selingerova, R. Belanova, P. Slampa, P. Pospisil, T. Kazda
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu klinické zkoušky, časopisecké články
NLK
BioMedCentral
od 2001-12-01
BioMedCentral Open Access
od 2001
Directory of Open Access Journals
od 2001
Free Medical Journals
od 2001
PubMed Central
od 2001
Europe PubMed Central
od 2001
ProQuest Central
od 2009-01-01
Open Access Digital Library
od 2001-01-01
Open Access Digital Library
od 2001-01-01
Open Access Digital Library
od 2001-01-01
Medline Complete (EBSCOhost)
od 2001-01-01
Health & Medicine (ProQuest)
od 2009-01-01
ROAD: Directory of Open Access Scholarly Resources
od 2001
Springer Nature OA/Free Journals
od 2001-12-01
- MeSH
- dospělí MeSH
- glioblastom * diagnostické zobrazování terapie diagnóza radioterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- magnetická rezonanční tomografie metody MeSH
- methionin * MeSH
- nádory mozku * diagnostické zobrazování terapie radioterapie diagnóza MeSH
- PET/CT metody MeSH
- plánování radioterapie pomocí počítače metody MeSH
- progrese nemoci * MeSH
- prospektivní studie MeSH
- radiofarmaka terapeutické užití MeSH
- radioizotopy uhlíku MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
BACKGROUND: Glioblastoma (GBM) is the most common and aggressive primary brain cancer. The treatment of GBM consists of a combination of surgery and subsequent oncological therapy, i.e., radiotherapy, chemotherapy, or their combination. If postoperative oncological therapy involves irradiation, magnetic resonance imaging (MRI) is used for radiotherapy treatment planning. Unfortunately, in some cases, a very early worsening (progression) or return (recurrence) of the disease is observed several weeks after the surgery and is called rapid early progression (REP). Radiotherapy planning is currently based on MRI for target volumes definitions in many radiotherapy facilities. However, patients with REP may benefit from targeting radiotherapy with other imaging modalities. The purpose of the presented clinical trial is to evaluate the utility of 11C-methionine in optimizing radiotherapy for glioblastoma patients with REP. METHODS: This study is a nonrandomized, open-label, parallel-setting, prospective, monocentric clinical trial. The main aim of this study was to refine the diagnosis in patients with GBM with REP and to optimize subsequent radiotherapy planning. Glioblastoma patients who develop REP within approximately 6 weeks after surgery will undergo 11C-methionine positron emission tomography (PET/CT) examinations. Target volumes for radiotherapy are defined using both standard planning T1-weighted contrast-enhanced MRI and PET/CT. The primary outcome is progression-free survival defined using RANO criteria and compared to a historical cohort with REP treated without PET/CT optimization of radiotherapy. DISCUSSION: PET is one of the most modern methods of molecular imaging. 11C-Methionine is an example of a radiolabelled (carbon 11) amino acid commonly used in the diagnosis of brain tumors and in the evaluation of response to treatment. Optimized radiotherapy may also have the potential to cover those regions with a high risk of subsequent progression, which would not be identified using standard-of-care MRI for radiotherapy planning. This is one of the first study focused on radiotherapy optimization for subgroup of patinets with REP. TRIAL REGISTRATION: NCT05608395, registered on 8.11.2022 in clinicaltrials.gov; EudraCT Number: 2020-000640-64, registered on 26.5.2020 in clinicaltrialsregister.eu. Protocol ID: MOU-2020-01, version 3.2, date 18.09.2020.
Department of Clinical Trials Masaryk Memorial Cancer Institute Brno Czech Republic
Department of Comprehensive Cancer Care Masaryk Memorial Cancer Institute 656 53 Brno Czech Republic
Department of Medical Imaging Masaryk Memorial Cancer Institute 656 53 Brno Czech Republic
Department of Neurosurgery St Anne's University Hospital Brno 656 91 Brno Czech Republic
Department of Neurosurgery University Hospital Brno 625 00 Brno Czech Republic
Department of Nuclear Medicine Masaryk Memorial Cancer Institute 656 53 Brno Czech Republic
Department of Pharmacology Faculty of Medicine Masaryk University 625 00 Brno Czech Republic
Department of Radiation Oncology Faculty of Medicine Masaryk University Brno Czech Republic
Department of Radiation Oncology Masaryk Memorial Cancer Institute 656 53 Brno Czech Republic
Faculty of Medicine Masaryk University 625 00 Brno Czech Republic
Citace poskytuje Crossref.org
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