E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with primary tumor likely diagnosis with 18F-FCH PET / CT or patients with local recurrence or distant shapes of the same histological |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10029105 |
E.1.2 | Term | Neoplasms malignant site unspecified NEC |
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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 |
Validate the Ch-18F PET / CT compared to MRI and neurosurgical target resulting from the histological biopsy material or surgically removed, both the lesion and the glial early relapse; validate the ability of 18F-Ch PET / CT to define, through the SUV, the grading of the disease, compared with the MRI-spectroscopy and histological findings; define the prognostic value of SUV in relation to survival |
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E.2.2 | Secondary objectives of the trial |
Relate the grading of the disease, defined by the SUV, with the neurosurgery (extension for end and radicalism in relation to the areas with the highest SUV) el`outcome patient (disease-free interval and survival time); evaluate the recurrence of disease after standard treatment, radiation therapy, with target conventionally designed solely with MRI images, and chemotherapy to determine if the resumption of the disease is in the area marked by high-grading SUV. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of both sexes, and more children under 18, with histological diagnosis of primary tumor likely diagnosis with 18F-FCH PET / CT or patients with local or distant recurrence of the same histological forms, from which they may find a more precise indication to chemotherapy or radiation treatments; in the case of female patients of childbearing age, the examination is performed only in the absence of documented pregnancy. |
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E.4 | Principal exclusion criteria |
Established pregnancy (if breastfeeding is discontinued for 24 hours) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Validate the Ch-18F PET / CT compared to MRI and neurosurgical target resulting from the histological biopsy material or surgically removed, both the lesion and the glial early relapse; validate the ability of 18F-Ch PET / CT to define, through the SUV, the grading of the disease, compared with the MRI-spectroscopy and histological findings; define the prognostic value of SUV in relation to survival |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |