- Work packages
- Clinical evaluation
- Participating companies
- Literature
Tab 1
GLIOMARK is segmented into 10 work packages. WP1 contains all regulatory support for preparation/conduct of clinical phases II and III (pivotal validation study), including clinical trial application. WP2-4 cover the phase II, with all preparatory work including training of trial site staff and qualification of all trial sites (WP2), trial conduct (WP3) and analysis (WP4). WP5-7 contain the phase III validation study, with preparatory work including training of trial site staff and qualification of all trial sites (WP5), conduct (WP6) and analysis with subsequent publication (WP7). WP8 comprises establishment of a GMP process and GMP manufacturing. Furthermore, distinct work packages are dedicated to management & administration (WP9), as well as to communication & commercialization (WP10).
The concept of this project was based on the innovative research work by Dr. Andreas Fotopoulos (Professor of Nuclear Medicine, University of Ioannina and University Hospital of Ioannina) and his group over the last decade.
The concept of this project was based on the innovative research work by Dr. Andreas Fotopoulos (Professor of Nuclear Medicine, University of Ioannina and University Hospital of Ioannina) and his group over the last decade.
Tab 2
Within the project, 2 clinical studies will be performed. In a phase II study the evaluation of technical and diagnostic performance will be conducted. The study has been conducted successfully with all endpoints met with sites in Hungary and France. Data will be used to decide on optimum L/N cut-off value to be used in phase III study.
Subsequently, a pivotal phase III validation study will be conducted which is blinded, controlled, multi-centered and randomised across Europe. This study serves as the pivotal study for application for EU marketing authorisation with EU orphan designation. The relationship between TTF uptake as biomarker for BBB permeability and differential glioma diagnosis, as well as between TTF uptake and histologic glioma grading/aggressiveness will be formally proven. This study is planned, clinical centres are identified and contracted and essentially the study is ready to start.
Subsequently, a pivotal phase III validation study will be conducted which is blinded, controlled, multi-centered and randomised across Europe. This study serves as the pivotal study for application for EU marketing authorisation with EU orphan designation. The relationship between TTF uptake as biomarker for BBB permeability and differential glioma diagnosis, as well as between TTF uptake and histologic glioma grading/aggressiveness will be formally proven. This study is planned, clinical centres are identified and contracted and essentially the study is ready to start.
Tab 3
- ConsulTech GmbH
- ProActina SA
Tab 1
Furthermore, ConsulTech assist companies of all sizes active in the fields of biotechnology, pharmaceutical development, medical technology and environmental technology by providing a one-stop-access to a network of experts in all areas of pharmaceutical and diagnostic development termed CONELIS (www.conelis.org).
ConsulTech is the coordinator of this project and its tasks include planning and conducting the clinical studies and financial grant management specifically regarding subcontract management. Furthermore, ConsulTech will lead the dissemination activities.
Tab 2
ProACTINA has been is responsible for production of tetrofosmin and lead all commercialization activities. It has the know-how of manufacturing the diagnostic product to be used in the clinical validation.
Tab 4
Publications relevant to GLIOMARK project have been authored by Prof. A. Fotopoulos who is lead clinical investigator in this project:
1. The value of 99mTc-tetrofosmin brain SPECT in predicting survival in patients with glioblastoma multiforme. George A Alexiou, Spyridon Tsiouris, Athanasios P Kyritsis, George Fotakopoulos, Anna Goussia, Spyridon Voulgaris, Andreas D Fotopoulos Journal of Nuclear Medicine 11/2010; 51(12):1923-6. · 5.77 Impact Factor
2. Metabolic Imaging of Brain Tumor by 99mTc-Tetrofosmin Scintitomography (book chapter). Spyridon Tsiouris, George Alexiou, Athanasios Papadopoulos and Andreas Fotopoulos In: “Diagnostic Techniques and Surgical Management of BrainTumors”, Edited by: Ana Lucia Abujamra, ISBN 978-953-307-589-1, Publisher: InTech, Publication date: September 2011
3. Evaluation of brain tumor recurrence by 99mTc-tetrofosmin SPECT: a prospective pilot study. G.A. Alexiou, A.D. Fotopoulos, A. Papadopoulos, A.P. Kyritsis, K.S. Polyzoidis, S. Tsiouris. Ann Nucl Med 21 (2007) 293-298. 1.507 Impact factor
4. Comparison of diffusion tensor, dynamic susceptibility contrast MRI and 99mTc-Tetrofosmin brain SPECT for the detection of recurrent high-grade glioma. Alexiou GA, Zikou A, Tsiouris S, Goussia A, Kosta P, Papadopoulos A, Voulgaris S, Tsekeris P, Kyritsis AP, Fotopoulos AD, Argyropoulou MI. Magn Reson Imaging. 2014 Sep;32(7):854-9. 2.02 Impact factor
5. Characterization of intracranial space-occupying lesions by 99mTc-Tetrofosmin SPECT. A.D. Fotopoulos, A.P. Kyritsis, S. Tsiouris, J. Al-Boucharali, A. Papadopoulos, S. Voulgaris, G.A. Alexiou. J Neurooncol 101 (2011) 83-89. 2.79 Impact factor
1. The value of 99mTc-tetrofosmin brain SPECT in predicting survival in patients with glioblastoma multiforme. George A Alexiou, Spyridon Tsiouris, Athanasios P Kyritsis, George Fotakopoulos, Anna Goussia, Spyridon Voulgaris, Andreas D Fotopoulos Journal of Nuclear Medicine 11/2010; 51(12):1923-6. · 5.77 Impact Factor
2. Metabolic Imaging of Brain Tumor by 99mTc-Tetrofosmin Scintitomography (book chapter). Spyridon Tsiouris, George Alexiou, Athanasios Papadopoulos and Andreas Fotopoulos In: “Diagnostic Techniques and Surgical Management of BrainTumors”, Edited by: Ana Lucia Abujamra, ISBN 978-953-307-589-1, Publisher: InTech, Publication date: September 2011
3. Evaluation of brain tumor recurrence by 99mTc-tetrofosmin SPECT: a prospective pilot study. G.A. Alexiou, A.D. Fotopoulos, A. Papadopoulos, A.P. Kyritsis, K.S. Polyzoidis, S. Tsiouris. Ann Nucl Med 21 (2007) 293-298. 1.507 Impact factor
4. Comparison of diffusion tensor, dynamic susceptibility contrast MRI and 99mTc-Tetrofosmin brain SPECT for the detection of recurrent high-grade glioma. Alexiou GA, Zikou A, Tsiouris S, Goussia A, Kosta P, Papadopoulos A, Voulgaris S, Tsekeris P, Kyritsis AP, Fotopoulos AD, Argyropoulou MI. Magn Reson Imaging. 2014 Sep;32(7):854-9. 2.02 Impact factor
5. Characterization of intracranial space-occupying lesions by 99mTc-Tetrofosmin SPECT. A.D. Fotopoulos, A.P. Kyritsis, S. Tsiouris, J. Al-Boucharali, A. Papadopoulos, S. Voulgaris, G.A. Alexiou. J Neurooncol 101 (2011) 83-89. 2.79 Impact factor