Humans
Glioblastoma
/ diagnostic imaging
Methionine
Disease Progression
Brain Neoplasms
/ diagnostic imaging
Prospective Studies
Positron Emission Tomography Computed Tomography
/ methods
Carbon Radioisotopes
Magnetic Resonance Imaging
/ methods
Male
Female
Adult
Middle Aged
Radiopharmaceuticals
/ therapeutic use
Radiotherapy Planning, Computer-Assisted
/ methods
Aged
11C-methionine
Clinical trial
Glioblastoma
Positron emission tomography
Radiopharmaceutical
Radiotherapy
Rapid early progression
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
15 Jun 2024
15 Jun 2024
Historique:
received:
27
12
2023
accepted:
03
06
2024
medline:
16
6
2024
pubmed:
16
6
2024
entrez:
15
6
2024
Statut:
epublish
Résumé
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 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 PET is one of the most modern methods of molecular imaging. 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.
Sections du résumé
BACKGROUND
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
METHODS
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
DISCUSSION
CONCLUSIONS
PET is one of the most modern methods of molecular imaging.
TRIAL REGISTRATION
BACKGROUND
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.
Identifiants
pubmed: 38879476
doi: 10.1186/s12885-024-12469-2
pii: 10.1186/s12885-024-12469-2
doi:
Substances chimiques
Methionine
AE28F7PNPL
Carbon Radioisotopes
0
Radiopharmaceuticals
0
Banques de données
ClinicalTrials.gov
['NCT05608395']
Types de publication
Journal Article
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
736Informations de copyright
© 2024. The Author(s).
Références
Wen PY, Weller M, Lee EQ, et al. Glioblastoma in adults: a Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) consensus review on current management and future directions. Neuro Oncol. 2020;22(8):1073–113. https://doi.org/10.1093/neuonc/noaa106 .
doi: 10.1093/neuonc/noaa106
pubmed: 32328653
pmcid: 7594557
Weller M, van den Bent M, Preusser M, et al. EANO guidelines on the diagnosis and treatment of diffuse gliomas of adulthood [published correction appears in Nat Rev Clin Oncol. 2022 May;19(5):357-358]. Nat Rev Clin Oncol. 2021;18(3):170–86. https://doi.org/10.1038/s41571-020-00447-z .
doi: 10.1038/s41571-020-00447-z
pubmed: 33293629
Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352(10):987–96. https://doi.org/10.1056/NEJMoa043330 .
doi: 10.1056/NEJMoa043330
pubmed: 15758009
Stupp R, Hegi ME, Mason WP, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomized phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009;10(5):459–66. https://doi.org/10.1016/S1470-2045(09)70025-7 .
doi: 10.1016/S1470-2045(09)70025-7
pubmed: 19269895
Lakomy R, Kazda T, Selingerova I, et al. Real-world evidence in glioblastoma: stupp’s regimen after a decade. Front Oncol. 2020;10:840. https://doi.org/10.3389/fonc.2020.00840 . Published 2020 Jul 3.
doi: 10.3389/fonc.2020.00840
pubmed: 32719739
pmcid: 7348058
Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017;318(23):2306–16. https://doi.org/10.1001/jama.2017.18718 .
doi: 10.1001/jama.2017.18718
pubmed: 29260225
pmcid: 5820703
Kazda T, Dziacky A, Burkon P, et al. Radiotherapy of Glioblastoma 15 Years after the Landmark Stupp’s Trial: more controversies than standards? Radiol Oncol. 2018;52(2):121–8. https://doi.org/10.2478/raon-2018-0023 .
doi: 10.2478/raon-2018-0023
pubmed: 30018514
pmcid: 6043880
Perry JR, Laperriere N, O’Callaghan CJ, et al. Short-course radiation plus temozolomide in elderly patients with glioblastoma. N Engl J Med. 2017;376(11):1027–37. https://doi.org/10.1056/NEJMoa1611977 .
doi: 10.1056/NEJMoa1611977
pubmed: 28296618
Farace P, Amelio D, Ricciardi GK, et al. Early MRI changes in glioblastoma in the period between surgery and adjuvant therapy. J Neurooncol. 2013;111(2):177–85. https://doi.org/10.1007/s11060-012-0997-y .
doi: 10.1007/s11060-012-0997-y
pubmed: 23264191
Palmer JD, Bhamidipati D, Shukla G, et al. Rapid Early Tumor Progression is Prognostic in Glioblastoma Patients. Am J Clin Oncol. 2019;42(5):481–6. https://doi.org/10.1097/COC.0000000000000537 .
doi: 10.1097/COC.0000000000000537
pubmed: 30973372
Lakomy R, Kazda T, Selingerova I, et al. Pre-radiotherapy progression after surgery of newly diagnosed glioblastoma: corroboration of new prognostic variable. Diagnostics (Basel). 2020;10(9):676. https://doi.org/10.3390/diagnostics10090676 . Published 2020 Sep 5.
doi: 10.3390/diagnostics10090676
pubmed: 32899528
pmcid: 7555958
Wee CW, Kim E, Kim TM, et al. Impact of interim progression during the surgery-to-radiotherapy interval and its predictors in glioblastoma treated with temozolomide-based radiochemotherapy. J Neurooncol. 2017;134(1):169–75. https://doi.org/10.1007/s11060-017-2505-x .
doi: 10.1007/s11060-017-2505-x
pubmed: 28547592
Merkel A, Soeldner D, Wendl C, et al. Early postoperative tumor progression predicts clinical outcome in glioblastoma-implication for clinical trials. J Neurooncol. 2017;132(2):249–54. https://doi.org/10.1007/s11060-016-2362-z .
doi: 10.1007/s11060-016-2362-z
pubmed: 28101701
pmcid: 5378726
Villanueva-Meyer JE, Han SJ, Cha S, Butowski NA. Early tumor growth between initial resection and radiotherapy of glioblastoma: incidence and impact on clinical outcomes. J Neurooncol. 2017;134(1):213–9. https://doi.org/10.1007/s11060-017-2511-z .
doi: 10.1007/s11060-017-2511-z
pubmed: 28567589
pmcid: 5563441
Hegi ME, Diserens AC, Gorlia T, et al. MGMT gene silencing and benefit from temozolomide in glioblastoma. New Engl J Med. 2005;352:997–1003. https://doi.org/10.1056/NEJMoa043331 .
doi: 10.1056/NEJMoa043331
pubmed: 15758010
Sana J, Hajduch M, Michalek J, et al. MicroRNAs and glioblastoma: Roles in core signalling pathways and potential clinical implications. J Cell Mol Med. 2011;15(8):1636–44. https://doi.org/10.1111/j.1582-4934.2011.01317.x .
doi: 10.1111/j.1582-4934.2011.01317.x
pubmed: 21435175
pmcid: 4373357
Ondracek J, Fadrus P, Sana J, et al. Global microRNA expression profiling identifies unique microrna pattern of radioresistant glioblastoma cells. Anticancer Res. 2017;37(3):1099–104.
doi: 10.21873/anticanres.11422
pubmed: 28314270
Kren L, Slaby O, Muckova K, et al. Expression of immune-modulatory molecules HLA-G and HLA-E by tumor cells in glioblastomas: an unexpected prognostic significance? Neuropathology. 2011;31(2):129–34. https://doi.org/10.1111/j.1440-1789.2010.01149.x .
doi: 10.1111/j.1440-1789.2010.01149.x
pubmed: 20667016
Zhao H, Wang S, Song C, et al. The prognostic value of MGMT promoter status by pyrosequencing assay for glioblastoma patients’ survival: a meta-analysis. World J Surg Oncol. 2016;14(1):261.
doi: 10.1186/s12957-016-1012-4
pubmed: 27733166
pmcid: 5062843
Karsy M, Neil JA, Guan J, et al. A practical review of prognostic correlations of molecular biomarkers in glioblastoma. Neurosurg Focus. 2015;38(3):E4. https://doi.org/10.3171/2015.1.FOCUS14755 .
doi: 10.3171/2015.1.FOCUS14755
pubmed: 25727226
Piwecka M, Rolle K, Belter A, et al. Comprehensive analysis of microRNA expression profile in malignant glioma tissues. Mol Oncol. 2015;9(7):1324–40. https://doi.org/10.1016/j.molonc.2015.03.007 .
doi: 10.1016/j.molonc.2015.03.007
pubmed: 25864039
pmcid: 5528820
Lakomy R, Sana J, Hankeova S, et al. MiR-195, miR-196b, miR-181c, miR-21 expression levels and O-6-methylguanine-DNA methyltransferase methylation status are associated with clinical outcome in glioblastoma patients. Cancer Sci. 2011;102(12):2186–90. https://doi.org/10.1111/j.1349-7006.2011.02092.x .
doi: 10.1111/j.1349-7006.2011.02092.x
pubmed: 21895872
pmcid: 11158343
Niyazi M, Andratschke N, Bendszus M, et al. ESTRO-EANO guideline on target delineation and radiotherapy details for glioblastoma. Radiother Oncol. 2023;184:109663. https://doi.org/10.1016/j.radonc.2023.109663 .
doi: 10.1016/j.radonc.2023.109663
pubmed: 37059335
Galldiks N, Niyazi M, Grosu AL, et al. Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients - a report of the PET/RANO group. Neuro Oncol. 2021;23(6):881–93. https://doi.org/10.1093/neuonc/noab013 .
doi: 10.1093/neuonc/noab013
pubmed: 33538838
pmcid: 8168815
Albert NL, Weller M, Suchorska B, et al. Response Assessment in Neuro-Oncology working group and European Association for Neuro-Oncology recommendations for the clinical use of PET imaging in gliomas. Neuro Oncol. 2016;18(9):1199–208. https://doi.org/10.1093/neuonc/now058 .
doi: 10.1093/neuonc/now058
pubmed: 27106405
pmcid: 4999003
Heiss P, Mayer S, Herz M, et al. Investigation of transport mechanism and uptake kinetics of O-(2-[18F]fluoroethyl)-L-tyrosine in vitro and in vivo. J Nucl Med. 1999;40:1367–73 PMID: 10450690.
pubmed: 10450690
Okubo S, Zhen HN, Kawai N, et al. Correlation of l-methyl- 11 C-methionine (MET) uptake with l-type amino acid transporter 1 in human gliomas. J Neurooncol. 2010;99(2):217–25. https://doi.org/10.1007/s11060-010-0117-9 .
doi: 10.1007/s11060-010-0117-9
pubmed: 20091333
Nariai T, Tanaka Y, Wakimoto H, et al. Usefulness of L-[methyl- 11 C] methionine-positron emission tomography as a biological monitoring tool in the treatment of glioma. J Neurosurg. 2005;103(3):498–507.
doi: 10.3171/jns.2005.103.3.0498
pubmed: 16235683
Kracht LW, Friese M, Herholz K, et al. Methyl-[11C]- l-methionine uptake as measured by positron emission tomography correlates to microvessel density in patients with glioma. Eur J Nucl Med Mol Imaging. 2003;30(6):868–73. https://doi.org/10.1007/s00259-003-1148-7 .
doi: 10.1007/s00259-003-1148-7
pubmed: 12692687
Herholz K, Holzer T, Bauer B, et al. 11C-methionine PET for differential diagnosis of low-grade gliomas. Neurology. 1998;50:1316–22. https://doi.org/10.1212/wnl.50.5.1316 .
doi: 10.1212/wnl.50.5.1316
pubmed: 9595980
Wen PY, Macdonald DR, Reardon DA, et al. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010;28(11):1963–72. https://doi.org/10.1200/JCO.2009.26.3541 .
doi: 10.1200/JCO.2009.26.3541
pubmed: 20231676
Niyazi M, Brada M, Chalmers AJ, et al. ESTRO-ACROP guideline “target delineation of glioblastomas.” Radiother Oncol. 2016;118(1):35–42. https://doi.org/10.1016/j.radonc.2015.12.003 .
doi: 10.1016/j.radonc.2015.12.003
pubmed: 26777122
Scoccianti S, Detti B, Gadda D, et al. Organs at risk in the brain and their dose-constraints in adults and in children: a radiation oncologist’s guide for delineation in everyday practice. Radiother Oncol. 2015;114(2):230–8. https://doi.org/10.1016/j.radonc.2015.01.016 .
doi: 10.1016/j.radonc.2015.01.016
pubmed: 25701297