Validation of blood-brain-barrier permeability as a glioma biomarker by means of the radiotracer 99mTc-tetrofosmin and single-photon emission computer tomography

Projektinformationen

GLIOMARK

ID Finanzhilfevereinbarung: 673737

DOI 10.3030/673737

Abgeschlossenes Projekt

EK-Unterschriftsdatum 29 Juli 2015

Startdatum 1 Juli 2015

Enddatum 31 Dezember 2021

Finanziert unter

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Gesamtkosten € 4 705 344,00

EU-Beitrag € 4 705 344,00

Koordiniert durch

CONSULTECH TECHNOLOGIEBERATUNG GMBH
Germany

Ziel

Objective of GLIOMARK is to clinically validate the permeability of the blood brain barrier (BBB) as an in vivo biomarker for the diagnosis and grading of gliomas. This will be accomplished by means of the radiotracer 99mTc-tetrofosmin (TTF) and the imaging technique Single-Photon Emission Computer To-mography (SPECT).
The outcome of GLIOMARK is GlioTect, a diagnostic kit containing handling/diagnostic instructions and tetrofosmin. The latter has to be reconstituted with 99mTc pertechnetate to yield TTF, which will be used in combination with SPECT.
Often computer tomography or magnetic resonance imaging are unable to detect low-grade gliomas or distinguish glioma from other diseases. Hence, brain biopsies are necessary for confirmation of diagnosis and grading of gliomas. GlioTect with TTF/SPECT enables reliable, fast differential diagnosis and grading of gliomas as non-invasive method. This has an immediate impact on the type and aggressiveness of subsequent therapies.
Gliomas are recognized as a rare tumor disease with poor prognosis and orphan diagnostic designation for GlioTect will guarantee 10 years of market exclusivity upon approval. ProActina, a Greek chemical-speciality SME having identified this innovative niche market opportunity could become global market leader in glioma diagnostics.
Development is at TLR level 6-7 and will be lifted to 9. Expected market application is the sale of GlioTect for preparation of TTF for use with SPECT. End users are hospitals that use the kit to reliably diagnose or exclude gliomas without the need for expensive equipment.
Taken together, the aggregated unique selling point of SPECT in combination with TTF (generated by means of GlioTect) is the first ever and only glioma diagnostic, which assesses a clinically validated glioma biomarker, has high reliability, reproducibility, sensitivity, as well as specificity, which is used to replace an invasive method, is safe, well tolerated, widely available and more affordable

Wissenschaftliches Gebiet

• medical and health sciences › clinical medicine › surgery
• medical and health sciences › basic medicine › pharmacology and pharmacy › pharmaceutical drugs
• medical and health sciences › clinical medicine › radiology › nuclear medicine
• medical and health sciences › clinical medicine › oncology
• engineering and technology › medical engineering › diagnostic imaging › magnetic resonance imaging

Programm/Programme

• H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme
• H2020-EU.3.1.3. - Treating and managing disease

Thema/Themen

• PHC-12-2014 - Clinical research for the validation of biomarkers and/or diagnostic medical devices

Aufforderung zur Vorschlagseinreichung

H2020-SMEInst-2014-2015

Andere Projekte für diesen Aufruf anzeigen

Unterauftrag

H2020-SMEINST-2-2014

Finanzierungsplan

SME-2 - SME instrument phase 2

Koordinator

CONSULTECH TECHNOLOGIEBERATUNG GMBH

• Netto-EU-Beitrag: € 3 328 646,76
• Adresse: MORGENSTERNSTRASSE 24 ; 12207 Berlin ; Deutschland
• KMU Die Organisation definierte sich zum Zeitpunkt der Unterzeichnung der Finanzhilfevereinbarung selbst als KMU (Kleine und mittlere Unternehmen). Ja:
  Region
  Berlin › Berlin › Berlin
• Region: Berlin › Berlin › Berlin
• Aktivitätstyp: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Gesamtkosten: € 3 328 646,76

Beteiligte (1)

PRO-ACTINA CHIMIKI TECHNOLOGIA ANONIMI ETAIRIA

Beteiligung beendet

Griechenland

• Netto-EU-Beitrag: € 1 376 697,24
• Adresse: DELFONSTREET 20 ; 15125 MAROUSI ATHENS
• KMU Die Organisation definierte sich zum Zeitpunkt der Unterzeichnung der Finanzhilfevereinbarung selbst als KMU (Kleine und mittlere Unternehmen). Ja:
  Aktivitätstyp
  Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Aktivitätstyp: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Gesamtkosten: € 1 376 697,24