E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neuroendocrine tumors |
Neuroendokrina tumörer |
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E.1.1.1 | Medical condition in easily understood language |
Neuroendocrine tumors origin from endocrine cells in the intestinal, pancreatic and bronchi-pulmonary system. Hormonal symptoms is seen in approximately half of the patients. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
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 |
This trial aim to evaluate the diagnostic and prognostic value of 68Ga-Dota-TOC in patients with neuroendocrine tumors. The findings will be compared with conventional imaging such as computed tomography (CT), magnetic resonance imaging (MR) as well as with biomarkers (Ki-67) and histopathology. All patients will undergo long term follow up. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with high suspicion of or with known neuroendocrine tumors are included and a base-line PET/CT is done for staging and depiction of the primary tumor is done. Patients with known neuroendocrine tumors with suspected recurrence is included and a PET/CT is done for evaluation. Patients with an accidentally diagnosed neuroendocrine tumor at surgery for other diagnoses are included after primary surgery and a PET/CT is done for staging.
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
Correlation to surgery results, histopathology and biomarkers when possible. Comparison with CT and MR for evaluation of accuracy. Quantification of uptakes of 68Ga-Dota-Toc at each examination and changes over time to correlate with disease development |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Varying due to clinical course of the disease. A base-line scan is intended before treatment start. The time to surgery differ due to other treatment possibilities. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Explorativ |
Explorative observational |
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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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THe trial ends when the patients has been examined once |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |