E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pheochromocytoma |
Feochromocytoom |
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E.1.1.1 | Medical condition in easily understood language |
Pheochromocytoma |
Feochromocytoom |
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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 | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034876 |
E.1.2 | Term | Pheochromocytoma |
E.1.2 | System Organ Class | 100000004864 |
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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 |
The primary objective of this study is to compare [18F]mFBG PET-CT imaging to conventional CT imaging performed in pheochromocytoma patients. |
Het hoofddoel van deze studie is het vergelijken van [18F]mFBG PET-CT beeldvorming met conventionele CT beeldvorming uitgevoerd in patiënten met een feochromocytoom. |
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E.2.2 | Secondary objectives of the trial |
- To determine the optimal time point of [18F]mFBG PET-CT imaging via comparison of SUV values 1 and 2 hours on PET-CT imaging. - To correlate [18F]mFBG PET findings with pathology and immunohistochemistry analysis of norepinephrine transporter. - To estimate radiation dose of [18F]mFBG in normal tissues using dynamic PATLAK imaging. - To perform a safety analysis of [18F]mFBG administration on clinical symptoms by Adverse Events outcomes.
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- Bepalen van het optimale tijdspunt voor het vervaardigen van de [18F]mFBG PET-CT scan. - Correleren van [18F]mFBG PET bevindingen met de pathologie en immunohistochemie analyse van de norepinephrine transporter. - Berekenen van de geabsobeerde stralingsdosis van [18F]mFBG van dynamische PET beeldvorming. - Bepalen van veiligheid en tolerantie van [18F]mFBG. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The patient has provided written informed consent authorization before participating in the study. - The patient is ≥18 years of age at the time of consent. - The patient has a diagnosis of pheochromocytoma with a known anatomical location or laboratory findings suspicious for pheochromocytoma defined as elevated serum/plasma metanefrines. - The patient should have surgery planned. - The patients should have had a CT scan at time of inclusion. - The patient has an ECOG status of Grade 0 – 2. |
- De patiënt heeft een ondertekende informed consent voorafgaand aan deelname aan deze studie. - De patiënt is 18 jaar over ouder op het moment van inclusie. - De patiënt met een (klinische verdenking op) feochromocytoom. - De patiënt staat ingepland voor chirurgische resectie. - De patiënt heeft een CT scan ondergaan op het moment van inclusie. - De patiënt heeft een ECOG status van Graad 0-2. |
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E.4 | Principal exclusion criteria |
- Patient is mentally or legally incapacitated. - Patient is pregnant or lactating. - Patient has active serious infections not controlled by antibiotics. - Patient is unable or unwilling to undergo PET-CT scanning or surgery. - Patient did receive interfering treatment between conventional CT scanning and [18F]mFBG PET-CT. |
- De patiënt is geestelijk of juridisch handelingsonbekwaam. - De patiënt is zwanger of geeft borstvoeding. - De patiënt heeft een actieve infectie welke niet onder controle is met antibiotica. - De patiënt wil niet, of kan niet een PET-CT scan ondergaan voorafgaand aan chirurgie. - De patiënt heeft een behandeling gehad tussen de CT scan en de PET-CT scan welke invloed heeft op de ziekte. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of detected pheochromocytoma lesions with pathological [18F]mFBG uptake, defined as focal uptake above surrounding normal tissue compared to number of lesions detected on protocollary conventional CT imaging. |
Aantal feochromocytoom laesies zichtbaar op [18F]mFBG PET-CT in vergelijking met CT. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Post acquisition of [18F]mFBG PET-CT imaging. |
Na het verkrijgen van de [18F]mFBG PET-CT beeldvorming. |
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E.5.2 | Secondary end point(s) |
1) Optimal time point of [18F]mFBG PET-CT imaging via comparison of SUV values at 1 and 2 hours on PET-CT imaging. 2) Correlation of [18F]mFBG PET findings with pathology and immunohistochemistry analysis of norepinephrine transporter. 3) Estimation of radiation dose of [18F]mFBG in normal tissues using dynamic PATLAK imaging 4) Safety analysis of [18F]mFBG administration on clinical symptoms will be evaluated by Adverse Events outcomes
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1) Optimale tijdspunt voor het verkrijgen van [18F]mFBG PET-CT beeldvorming op 1 en 2 uur. 2) Correlatie tussen [18F]mFBG PET-CT bevindingen met pathologie en immunohistochemie analyse van de norepinephrine transporter. 3) Geabsorbeerde stralingsdosis van [18F]mFBG door middel van een dynamische PET scan. 4) 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 surgery; 3) Post acquisition of [18F]mFBG PET-CT; 4) Up to 72 hours post injection. |
1) Na het verkrijgen van de [18F]mFBG PET-CT; 2) Na de chirurgie; 3) Na het verkrijgen van de [13F]mFBG PET-CT; 4) 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 | 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
| 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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |