GLIOMARK1 clinical study successfully completed
17/05/18 10:55
The GLIOMARK consortium is delighted to announce that the Gliomark1 Phase II clinical study has been successfully completed.
GLIOMARK is a collaborative research and development project between Greek SME ProActina SA and ConsulTech GmbH. This project receives funding from the European Union´s Horizon 2020 Research and Innovation, SME Instrument Phase II programme (GA No. 673737).
Part of this project is the planning and conduct of Gliomark1, a Phase II exploratory study assessing the technical performance of 99mTc-tetrofosmin for the differentiation of tumour recurrence vs. radiation-necrosis in patients with high grade brain tumours following initial treatment (EudraCT No.: 2015-005573-21, ClinicalTrials.gov ID: NCT02971319). Find out more about this project on it's homepage www.gliomark.eu.
The study, conducted in 6 large glioma centres in Europe, met all end-points, regarding both technical and diagnostic performance of 99mTc-tetrofosmin, and sets a strong basis for the design of a successful phase III confirmatory study.
The Consortium wishes to thank all the Principal Investigators and their dedicated teams, as well as our highly experienced team of Medical Advisors for their impactful contribution and commitment to bringing the study to its successful completion.
Dr Alex Strongilos, CEO of proACTINA, stated that “the successful completion of the phase II study is a major advancement towards the completion of this ambitious project and it constitutes a very strong foundation for the upcoming Phase III study”.
Dr Daniel Schubart, Managing Director of ConsulTech, stated that “We have now reached a very important milestone of the GLIOMARK project and we are very enthusiastic about this significant achievement”.
Part of this project is the planning and conduct of Gliomark1, a Phase II exploratory study assessing the technical performance of 99mTc-tetrofosmin for the differentiation of tumour recurrence vs. radiation-necrosis in patients with high grade brain tumours following initial treatment (EudraCT No.: 2015-005573-21, ClinicalTrials.gov ID: NCT02971319). Find out more about this project on it's homepage www.gliomark.eu.
The study, conducted in 6 large glioma centres in Europe, met all end-points, regarding both technical and diagnostic performance of 99mTc-tetrofosmin, and sets a strong basis for the design of a successful phase III confirmatory study.
The Consortium wishes to thank all the Principal Investigators and their dedicated teams, as well as our highly experienced team of Medical Advisors for their impactful contribution and commitment to bringing the study to its successful completion.
Dr Alex Strongilos, CEO of proACTINA, stated that “the successful completion of the phase II study is a major advancement towards the completion of this ambitious project and it constitutes a very strong foundation for the upcoming Phase III study”.
Dr Daniel Schubart, Managing Director of ConsulTech, stated that “We have now reached a very important milestone of the GLIOMARK project and we are very enthusiastic about this significant achievement”.