E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary and secondary brain tumors |
Igazolt primer vagy metasztatikus agydaganat |
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E.1.1.1 | Medical condition in easily understood language |
Brain tumors and metastases |
Agydaganok és áttétek |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Clinical value of F-18 FET PET-CT in various types of brain tumor, compared to MRI |
Elsődleges végpont: F18 FET PET/CT vizsgálat klinikai értéke különböző szövettani altípusú agytumorokban összevetve az MRI-vel. |
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E.2.2 | Secondary objectives of the trial |
Quantitave F-18 FET PET-CT as a biomarker for the effectiveness of therapy, and for assessing prognosis |
Másodlagos végpont: Quantitatív F18 FET PET/CT, mint követő biomarker a terápia hatékonyság és prognózis becslésében. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
histologically confirmed primary or secondary brain tumor previous MRI study (T1WI, PDWI, T2WI, postcontrast T1WI) clinical history is available cooperating patient
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hisztológiailag igazolt primer vagy szekunder agydaganat a vizsgálatot megelőző MRI felvétel (T1WI, PDWI, T2WI, posztkontraszt T1WI) a beteg klinikai kórtörténete rendelkezésre áll kooperáló beteg, aki megértette a vizsgálatot és beleegyezését aláírásával igazolta és képes 30-60 percig nyugalomban feküdni a kamera alatt.
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E.4 | Principal exclusion criteria |
non-cooperating patient clinical data are not available claustrophobia patient refused participation pregnancy or breast feeding |
nem kooperáló beteg a klinikai adatok nem hozzáférhetők klausztrofóbia az anamnézisben a beteg visszautasította a vizsgálatot terhesség és szoptatás
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E.5 End points |
E.5.1 | Primary end point(s) |
Accessing the clinical value of F-18 FET PET-CT in various types of brain tumor, compared to MRI. |
Elsődleges végpont: F18 FET PET/CT vizsgálat klinikai értéke különböző szövettani altípusú agytumorokban összevetve az MRI-vel. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of this endpoint Dec. 20, 2016 |
Értékelés végpontja . 2016. 12. 20. |
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E.5.2 | Secondary end point(s) |
Testing the applicability of quantitave F-18 FET PET-CT as a biomarker for the effectiveness of therapy, and for estimating prognosis |
Másodlagos végpont: Quantitatív F18 FET PET/CT, mint követő biomarker a terápia hatékonyság és prognózis becslésében. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluation of this endpoint Dec. 20, 2016 |
Értékelés végpontja . 2016. 12. 20. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |