E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neuroblastoma |
Neuroblastoom |
|
E.1.1.1 | Medical condition in easily understood language |
Neuroblastoma |
Neuroblastoom |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029260 |
E.1.2 | Term | Neuroblastoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare [18F]mFBG PET-CT imaging for neuroblastoma patients with the current standard of imaging, [123I]mIBG SPECT, using the SIOPEN score for skeletal lesions and the number of detected soft tissue lesions as endpoints. |
Het vergelijken bij neuroblastoompatiënten van [18F]mFBG PET-CT beeldvorming met de huidige beeldvormingsstandaard, [123I]mIBG SPECT, gebruikmakend van de SIOPEN score voor skeletlaesies en het absolute aantal weke delen laesies als eindpunten. |
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E.2.2 | Secondary objectives of the trial |
To determine the optimal time point for [18F]mFBG PET-CT acquisition;
To calculate, in a subset of patients, the radiation absorbed dose of [18F]mFBG for patients using dynamic PET imaging;
To determine the short-term safety and tolerability of [18F]mFBG .
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Bepalen van het optimale tijdspunt voor het vervaardigen van de [18F]mFBG PET-CT scan;
Berekenen (in een deel van de proefpersonen) van de geabsorbeerde stralingsdosis van [18F]mFBG gebruikmakend van dynamische PET beeldvorming;
Bepalen van de veiligheid en tolerantie van [18F]mFBG . |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with a (clinical suspicion of) neuroblastoma who are referred for [123I]mIBG imaging;
Age 0 – 18 years;
Written informed consent from patients and/or from parents or legal guardians, according to local law and regulations.
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Patiënten met een (klinische verdenking op) neuroblastoom die verwezen zijn voor [123I]mIBG beeldvorming;
Leeftijd 0 - 18 jaar;
Getekende toestemmingsformulier van patiënt en/of ouders/wettelijke vertegenwoordigers. |
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E.4 | Principal exclusion criteria |
Pregnancy of patient
Age > 18 years old
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Zwangerschap van patiënt
Leeftijd > 18 jaar |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of neuroblastoma lesions detected with [18F]mFBG PET-CT compared to [123I]mIBG imaging, segment based using SIOPEN scoring method;
2. Absolute number of soft tissue lesions detected with [18F]mFBG PET-CT compared to [123I]mIBG imaging.
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1. Aantal neuroblastoom laesies zichtbaar op [18F]mFBG PET-CT in vergelijking met [123I]mIBG beeldvorming, gebruik makend van de SIOPEN score methode;
2. Absolute aantal weke delen laesies zichtbaar op [18F]mFBG PET-CT in vergelijking met [123I]mIBG beeldvorming |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Post acquisition of [18F]mFBG PET-CT and [123I]mIBG imaging |
Na het verkrijgen van de [18F]mFBG PET-CT and [123I]mIBG beeldvorming |
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E.5.2 | Secondary end point(s) |
1. Optimal imaging time point of [18F]mFBG PET acquisition (60 minutes vs 120-150 minutes post injection
2. Radiation absorbed dose of [18F]mFBG from patients that underwent a dynamic PET-CT scan
3. Adverse events encountered after 18F-mFBG injection.
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1. Optimale tijdspunt voor het verkrijgen van [18F]mFBG PET-CT beeldvorming (60 minuten vs 120-150 minuten na toediening);
2. Geabsorbeerde stralingsdosis van [18F]mFBG in patiënten die een dynamische PET scan hebben ondergaan
3. Adverse events na toediening van [18F]mFBG. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.Post acquisition of [18F]mFBG PET-CT;
2. Post acquisition of [18F]mFBG PET-CT;
3. Up to 72 hours post injection. |
1. Na het verkrijgen van de [18F]mFBG PET-CT;
2. Na het verkrijgen van de [18F]mFBG PET-CT;
3. Tot 72 uur na toediening van de [18F]mFBG. |
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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 | Yes |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | No |
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.8.5 | 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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LVLS |
Laatste bezoek van laatste proefpersoon |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |