E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 |
The main study aim of the study is to examine the feasibility of detecting PGLs using 68Ga-exendin-4 PET/CT. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are:
• Determining the optical timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT.
• Comparing quantitative imaging parameters (SUV, tumor-to-background ratio, contract-to-noise ratio) between 68Ga-exendin-4 PET/CT and SSTR PET/CT.
• Assessing the correlation between GLP-1R expression and tracer uptake in the PGLs.
• Correlating quantitative imaging results and IHC data to the genetic origin of the PGLs.
• Assessing safety / side effects of 68Ga-exendin-4 in patients with PGL
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Proven PGL with a single tumor detected using standard diagnostic imaging
• No evidence of metastatic disease
• SSTR PET performed
• Scheduled for surgery
• Able to sign informed consent
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E.4 | Principal exclusion criteria |
• Breast feeding
• Pregnancy or the wish to become pregnant within 1 month
• Calculated creatinine clearance below 40ml/min
• Evidence of other malignancy than PGL in conventional imaging (suspicious liver, bone and lung lesions)
• Age < 18 years
• Not able to sign informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Detection rate of PGLs using 68Ga-exendin-4 PET/CT |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT.
• Comparison of quantitative imaging parameters (SUV, tumor-to-background ratio, contract-to-noise ratio) between 68Ga-exendin-4 PET, 18F-FDG PET and SSTR PET.
• Correlation between GLP-1R expression and tracer uptake in the PGLs.
• Correlation quantitative imaging results and IHC data to the genetic origin of the PGLs.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
First endpoint after inclusion of 3 participants, the rest at the end of the trial |
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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 | Yes |
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 | 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 | No |
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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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 |