11C-methionine in Diagnostics and Management of Glioblastoma Multiforme Patients (GlioMET)

NCT05608395 | Completed Phase 2

• 1 other identifier: MOU-2020-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Glioblastoma multiforme (GBM) is the most common primary brain cancer. The treatment of GBM consists of a combination of surgery and subsequent oncological therapy, i.e. radiotherapy, chemotherapy, or combination of both at te same time. If post-operative oncological therapy involves irradiation, magnetic resonance imaging (MRI) is planned. Unfortunately, in some cases, a very early worsening (progression) or return (recurrence) of the disease is observed several weeks after the surgery, i.e. rapid early progression (REP). Radiotherapy planning is based on this MRI in all patients. However, a subset of patients with REP have a less favorable prognosis with this treatment management. The investigators therefore assume that these patients need a more thorough examination to form a precise radiotherapy plan. The project focuses on this group of patients with a less favorable prognosis (with a more aggressive disease). Patients who develop REP within approximately 6 weeks after surgery will have PET/CT (positron emission tomography in combination with computed tomography) examinations using the radiopharmaceutical 11C-methionine in addition to standard practice. PET is one of the most modern methods of molecular imaging, a non-invasive in vivo method that allows physicians to study processes in the human body using radiolabeled radiopharmaceuticals. 11C-methionine is an example of a radiolabeled (carbon 11) amino acid - a source of energy for tumor cells and a building material for new proteins. This radiopharmaceutical is commonly used in the diagnosis of brain tumors and in the evaluation of response to treatment. For patients who undergo this examination, the radiotherapy planning will be adjusted based on it. The purpose of clinical trial is to improve the prospects of patients with REP.

Conditions

Glioblastoma Multiforme

Keywords

rapid early progression; 11C-Methionine; MET-PET/CT

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) in 11C-Methionine PET/CT Arm vs. PFS in Arm Ahist

  PFS in 11C-Methionine PET/CT Arm vs. PFS in historical cohort (Arm A/hist./). PFS timeframe = start of radiotherapy / progression of disease or death.

  44 months

Secondary Outcomes (11)

• Rapid-Early-Progression incidence

  38 months

• Overall survival in 11C-Methionine PET/CT Arm vs. overall survival in Arm Ahist

  44 months

• Progression free survival in 11C-Methionine PET/CT Arm vs. progression free survival in Arm Ahist.

  44 months

• Biomarkers I

  38 months

• Biomarkers II

  38 months

Study Arms (2)

11C-Methionine PET/CT Arm

EXPERIMENTAL

The cohort consists of patients: * diagnosed with GB * with confirmed REP * indicated for adjuvant chemoradiotherapy * will undergo the 11C-MET PET/CT

Drug: 11C-Methionine PET/CT

Arm A-historical

NO INTERVENTION

The cohort consists of a historical group of patients collected in the period 2014-2018: * with diagnosed GB * with confirmed REP * were indicated for adjuvant chemoradiotherapy

Interventions

11C-Methionine PET/CT DRUG

11C-Methionine PET/CT will be applied in patients in 11C-Methionine PET/CT Arm, based on planning MRI, prior chemo/radiotherapy (2 weeks prior C1D1)

Also known as: Methionine application

11C-Methionine PET/CT Arm

Eligibility Criteria

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

You may qualify if:

• The subject is a person with a histologically proven diagnosis of glioblastoma (GB) according to WHO 2016.
• The subject is male or female, aged 18 years or older.
• Performance status (PS) according to ECOG (Eastern Cooperative Oncology Group) 0-2.
• Healed operation wound.
• Post-operative MR up to 72 hours.
• Indication to adjuvant chemoradiotherapy.
• Patient has to express his/her informed consent and sign the form before the screening period.
• Detected rapid early progression.
• Patient must achieve following values of laboratory parameters in the peripheral blood during the screening period:
• neutrophiles (total count) ≥1500/mm3
• platelets (total count) ≥100 000/mm3
• hemoglobin ≥ 9,0 g/dL
• serum creatinin ≤1,5x of upper limit of normal, ULN
• total bilirubin 1,5x ULN, unless documented Gilbert's syndrome, for which bilirubin ≤ 3x ULN is permitted
• AST/ALT ≤3x ULN

You may not qualify if:

• Prior brain surgery.
• Prior radiotherapy targeting brain.
• The history of active/currently treated cancer (solid tumor); the exceptions are: non-melanoma skin cancer, in situ bladder carcinoma, in situ gastric cancer, in situ colorectal carcinoma, in situ cervical carcinoma, in situ breast cancer.
• Any systemic disease or health condition that might posses a risk at anticancer therapy and imaging techniques (MRI, MET PET).
• Patients must not have substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Patients must not have any evidence of ongoing (active) infection (HIV, hepatitis A, B, C).
• Pregnant and/or breastfeeding women.
• Patient who disagree and refuses to sign an Informed consent.

Sponsors & Collaborators

• Masaryk Memorial Cancer Institute: lead

Study Sites (1)

Masaryk Memorial Cancer Institute

Brno, Czech Republic, 65653, Czechia

Location

Related Publications (13)

• Lakomy R, Fadrus P, Slampa P, Svoboda T, Kren L, Lzicarova E, Belanova R, Sikova I, Poprach A, Schneiderova M, Prochazkova M, Sana J, Slaby O, Smrcka M, Vyzula R, Svoboda M. [Multimodal treatment of glioblastoma multiforme: results of 86 consecutive patients diagnosed in period 2003-2009]. Klin Onkol. 2011;24(2):112-20. Czech.

  PMID: 21644366 BACKGROUND

• Weller M, van den Bent M, Tonn JC, Stupp R, Preusser M, Cohen-Jonathan-Moyal E, Henriksson R, Le Rhun E, Balana C, Chinot O, Bendszus M, Reijneveld JC, Dhermain F, French P, Marosi C, Watts C, Oberg I, Pilkington G, Baumert BG, Taphoorn MJB, Hegi M, Westphal M, Reifenberger G, Soffietti R, Wick W; European Association for Neuro-Oncology (EANO) Task Force on Gliomas. European Association for Neuro-Oncology (EANO) guideline on the diagnosis and treatment of adult astrocytic and oligodendroglial gliomas. Lancet Oncol. 2017 Jun;18(6):e315-e329. doi: 10.1016/S1470-2045(17)30194-8. Epub 2017 May 5.

  PMID: 28483413 BACKGROUND

• Kazda T, Dziacky A, Burkon P, Pospisil P, Slavik M, Rehak Z, Jancalek R, Slampa P, Slaby O, Lakomy R. Radiotherapy of Glioblastoma 15 Years after the Landmark Stupp's Trial: More Controversies than Standards? Radiol Oncol. 2018 Jun 6;52(2):121-128. doi: 10.2478/raon-2018-0023. eCollection 2018 Jun.

  PMID: 30018514 BACKGROUND

• Blumenthal DT, Gorlia T, Gilbert MR, Kim MM, Burt Nabors L, Mason WP, Hegi ME, Zhang P, Golfinopoulos V, Perry JR, Hyun Nam D, Erridge SC, Corn BW, Mirimanoff RO, Brown PD, Baumert BG, Mehta MP, van den Bent MJ, Reardon DA, Weller M, Stupp R. Is more better? The impact of extended adjuvant temozolomide in newly diagnosed glioblastoma: a secondary analysis of EORTC and NRG Oncology/RTOG. Neuro Oncol. 2017 Aug 1;19(8):1119-1126. doi: 10.1093/neuonc/nox025.

  PMID: 28371907 BACKGROUND

• Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

  PMID: 15758009 BACKGROUND

• Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.

  PMID: 19269895 BACKGROUND

• Pirzkall A, McGue C, Saraswathy S, Cha S, Liu R, Vandenberg S, Lamborn KR, Berger MS, Chang SM, Nelson SJ. Tumor regrowth between surgery and initiation of adjuvant therapy in patients with newly diagnosed glioblastoma. Neuro Oncol. 2009 Dec;11(6):842-52. doi: 10.1215/15228517-2009-005.

  PMID: 19229057 BACKGROUND

• Wee CW, Kim E, Kim TM, Park CK, Kim JW, Choi SH, Yoo RE, Lee ST, Kim IH. Impact of interim progression during the surgery-to-radiotherapy interval and its predictors in glioblastoma treated with temozolomide-based radiochemotherapy. J Neurooncol. 2017 Aug;134(1):169-175. doi: 10.1007/s11060-017-2505-x. Epub 2017 May 25.

  PMID: 28547592 BACKGROUND

• Merkel A, Soeldner D, Wendl C, Urkan D, Kuramatsu JB, Seliger C, Proescholdt M, Eyupoglu IY, Hau P, Uhl M. Early postoperative tumor progression predicts clinical outcome in glioblastoma-implication for clinical trials. J Neurooncol. 2017 Apr;132(2):249-254. doi: 10.1007/s11060-016-2362-z. Epub 2017 Jan 18.

  PMID: 28101701 BACKGROUND

• Katsanos AH, Alexiou GA, Fotopoulos AD, Jabbour P, Kyritsis AP, Sioka C. Performance of 18F-FDG, 11C-Methionine, and 18F-FET PET for Glioma Grading: A Meta-analysis. Clin Nucl Med. 2019 Nov;44(11):864-869. doi: 10.1097/RLU.0000000000002654.

  PMID: 31205150 BACKGROUND

• Grosu AL, Weber WA, Riedel E, Jeremic B, Nieder C, Franz M, Gumprecht H, Jaeger R, Schwaiger M, Molls M. L-(methyl-11C) methionine positron emission tomography for target delineation in resected high-grade gliomas before radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):64-74. doi: 10.1016/j.ijrobp.2005.01.045.

  PMID: 16111573 BACKGROUND

• Matsuo M, Miwa K, Tanaka O, Shinoda J, Nishibori H, Tsuge Y, Yano H, Iwama T, Hayashi S, Hoshi H, Yamada J, Kanematsu M, Aoyama H. Impact of [11C]methionine positron emission tomography for target definition of glioblastoma multiforme in radiation therapy planning. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):83-9. doi: 10.1016/j.ijrobp.2010.09.020. Epub 2010 Nov 20.

  PMID: 21095072 BACKGROUND

• Lakomy R, Lojova M, Souckova L, Hynkova L, Polachova K, Vasina J, Demlova R, Poprach A, Sana J, Prochazka T, Smrcka M, Fadrus P, Jancalek R, Selingerova I, Belanova R, Slampa P, Pospisil P, Kazda T. 11C-methionine in the diagnostics and management of glioblastoma patients with rapid early progression: nonrandomized, open label, prospective clinical trial (GlioMET). BMC Cancer. 2024 Jun 15;24(1):736. doi: 10.1186/s12885-024-12469-2.

  PMID: 38879476 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Radek Lakomy, MD, Ph.D.

  Masaryk Memorial Cancer Institute, Dept. of Comprehensive Cancer Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 11C-Methionine PET/CT Arm is to be compared to historical cohort A(hist.).

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: November 8, 2022
• Study Start: December 4, 2020
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)