E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with neuroendocrine tumors, who are going to be diagnosed/evaluated with 68Ga-DOTA-TATE PET/CT instead of standard Octreoscan |
Patienter med neuroendokrina tumörer, som skall diagnostiseras/utvärderas med den radioaktiva isotopen 68Ga-DOTA-TATE PET/CT istället för Octreoscan som idag är standard. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with neuroendocrine tumors. |
Patienter med neuroendokrina tumörer. |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062476 |
E.1.2 | Term | Neuroendocrine tumor |
E.1.2 | System Organ Class | 100000004864 |
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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 |
To collect data from patients with neuroendocrine tumors, diagnosed and followed up by the radioactive isotope 68Ga-DOTA-TATE, and to correlate these data with other imaging techniques and data from the patients medical records. |
Att insamla data från patienter med neuroendokrina tumörer, som diagnostiserats och följts upp med den radioaktiva isotopen 68Ga DOTA-TATE, och att korrelera dessa data med andra tekniker och med uppgifter i patientens medicinska journal. |
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E.2.2 | Secondary objectives of the trial |
To describe how the use of long acting somastotatine analogue influences the result of 68Ga-DOTA-TATE PET/CT
Amont the population with metastatic neuroendocrine tumor, and are planned for treatment with 177Lu-DOTA-TATE create a model for objective quantification of the uptake of 68Ga-DOTA-TATE in tumor versus normal tissue and compare with the usual "Krenning-index, now beeing used as a predictive factor selection of patients for peptide receptor radionuclide therapy based on octreotid scintigraphy. |
Att beskriva hur användandet av långverkande somastostatin-analog påverkar resultatet av 68Ga-DOTA-TATE PET/CT hos patienter med neuroendokrina tumörer.
Bland patienter som har metastatisk neuroendokrin tumör och som planeras för behandling med 177Lu-DOTA-TATE skapa en modell för objektiv kvantifiering av upptaget av 68Ga-DOTA-TATE i tumör versus normalvävnad, och jämföra det med det sedvanliga "Krenning-index" som för närvarande används som prediktiv faktor för selektion av patienter för peptid receptor radionuklid terapi. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18 years or more
Signed written informed concent
Follow up of previous diagnosed neuroendocrine tumor or is under investigation for suspect neuroendocrine tumor |
Ålder 18 år eller mer
Skriftligt bekräftat informerat samtycke
Under uppföljning för tidigare diagnosticerad neuroendokrin tumör, eller är under utredning för misstänkt neuroendokrin tumör |
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E.4 | Principal exclusion criteria |
Pregnancy or breastfeeding
Age less than 18 years |
Graviditet eller amning
Ålder understigande 18 år |
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E.5 End points |
E.5.1 | Primary end point(s) |
To describe the result of 68Ga-DOTA-TATE PET/CT regarding metastases and intensity of uptake and to correlate this with other imaging techniques and data from the patients medical records with respect to disease progression. |
Beskrivning av resultatet av 68Ga-DOTA-TATE PET/CT med avseende på metastasutbredning och upptagsintensitet och korrelera detta till andra avbildande metoder och uppgifter ur patientens journal avseende sjukdomsförlopp. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At diagnosis, and follow up. |
Vid diagnos och uppföljande utvärderingar |
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E.5.2 | Secondary end point(s) |
Not applicable. |
Ej tillämpbart. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable. |
Ej tillämpbart. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |