E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with neuroendocrine tumors (gastro-entero-pancreatic and bronchopulmonary) |
Patienter med neuroendokrine tumorer |
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E.1.1.1 | Medical condition in easily understood language |
Neuroendocrine tumors |
Patienter med neuroendokrine tumorer |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067518 |
E.1.2 | Term | Pancreatic neuroendocrine tumor |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10078184 |
E.1.2 | Term | Neuroendocrine tumor of the lung metastatic |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10078183 |
E.1.2 | Term | Neuroendocrine tumor of the lung |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062476 |
E.1.2 | Term | Neuroendocrine tumor |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10077560 |
E.1.2 | Term | Gastroenteropancreatic neuroendocrine tumor disease |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068916 |
E.1.2 | Term | Pancreatic neuroendocrine tumor metastatic |
E.1.2 | System Organ Class | 100000004864 |
|
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 |
In this study with angiogenesis PET we include patients diagnosed with neuroendocrine tumors in order to investigate the diagnostic performance of angiogenesis PET |
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E.2.2 | Secondary objectives of the trial |
The prognostic value of angiogenesis PET for predicting progression free survival, disease specific survival and overall survival. An angiogenesis PET will be performed as a baseline scan and the patients will be followed for 12 months |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age > 18 years • Diagnosed with gastro-enetero-pancreatic Neuroendocrine Tumors (GEP-NET; grade: G1-G3) or broncho-pulmonary NET. • WHO performance status 0-2 • Must be able to read and understand the patient information in Danish and to give informed consent
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E.4 | Principal exclusion criteria |
• Pregnancy • Breast-feeding • Weight more than the maximum weight limit for the PET/CT bed of the scanner (140 kg) • History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E[c(RGDyK)]2 • In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer (SCLC)
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E.5 End points |
E.5.1 | Primary end point(s) |
Angiogenesis PET/CT with the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 can be used to visualize neuroendocrine tumors (grade G1-G3) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Uptake of the radioligand in tumor lesions from angiogenesis PET performed 45 minutes post injection of 68Ga-NODAGA-E[c(RGDyK)]2 |
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E.5.2 | Secondary end point(s) |
Prognostic information (correlation of 68Ga-NODAGA-E[c(RGDyK)]2 uptake in tumor lesions) and 1. progression free survival 2. disease specific survival 3. overall survival |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Progression free survival : 12 months 2. Disease specific survival: 6 months 3. Overall survival: 12 months |
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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 | 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.8.3 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |