E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neuroendocrine tumour |
Neuroendocrin tumör |
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E.1.1.1 | Medical condition in easily understood language |
Neuroendcrine tumours emanate from endocrine cells, most commonly in the small bowel, broncho-pulmonary system and colon and give hormonal symptoms in half of the patients. |
Neuroendokrina tumörer uppstår i spridda endokrina celler, vanligen i tunntarm, lunga-luftrör och tjocktarm. Cirka hälften av patienterna med neuroendokrina tumörer har hormonella symptom. |
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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 is an exploratory observational Phase II trial to investigate the imaging capacity of 68Ga-DOTATOC-PET/CT in patients with neuroendocrine tumours and medullary thyroid cancer in comparison with either Whole-Body-Magnetic Resonance Imaging using Diffusion Weighted Signal sequences (DWI-MRI) and in comparison with conventional radiological procedures such as CT and US and long term follow-up. |
Detta är en explorativ Fas II studie för att pröva den diagnostiska kapaciteten hos 68Ga-DOTATOC-PET/CT i patienter med neuroendokrina tumörer i jämförelse med helkroppsundersökning med magnetkamera med s.k. diffusionsviktade registreringar och i jämförelse med konventionella radiologiska metoder såsom CT och ultraljud samt med radiologisk och klinisk långtidsuppföljning. |
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E.2.2 | Secondary objectives of the trial |
There are no secondary endpoints in this trial |
Det finns inga secondary endpoints i denna kliniska prövning |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with neueoendocrine tumour in need of somatostatin receptor imaging for staging of the disease, depiction of the primary tumour and patients with medullary thyroid cancer in need for pre-operative lymph node mapping. |
Patienter med neuroendokrin tumör med behov av somatostatinreceptoravbildning för stadieindelning av sjukdomen, diagnostik av primärtumören och patienter med medullär thyroideacancer i behov av preoperativ kartläggning av lymfkörtelmetastasering. |
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E.4 | Principal exclusion criteria |
Age less than 18 years Claustrofobia |
Ålder yngre än 18 år Klaustrofobi |
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E.5 End points |
E.5.1 | Primary end point(s) |
When both PET/CT and WB-MRI has been performed and compared and correlated to findings at surgery, histopathology and radiological and clinical follow-up |
När både PET/CT och WB-MRT har utförts och jämförts och korrelerats till resultat vid kirurgi, histopatologi och radiologisk och klinisk uppföljning. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Varying, because some patients undergo surgery and histopathology immediately after PET/CT and MRI and others needs to be followed radiological and clinically for longer time. |
Varierande eftersom vissa patienter genomgår kirurgi och histopatologi omgående och andra patienter behöver följas lång tid radiologisk och kliniskt. |
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E.5.2 | Secondary end point(s) |
There are no secondary endpoints in this trial |
Det finns inga secondary endpoints i denna pröving. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
There are no secondary endpoints in this trial |
Det finns inga secondary endpoints i denna pröving. |
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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 | 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 |
Exploratory 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
|
The trial ends when PET/CT and WB-MRI has been performed and compared and correlated to findings at surgery, histopathology and radiological and clinicalfollow-up. |
Studien avslutas när PET/CT och WB-MRT utförst och jämförts och korrelerats mot radiologisk och klinisk uppföljning. |
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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 | |