E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
GastroEnteroPancreatic NeuroEndocrine Tumours (GEP-NET's) |
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E.1.1.1 | Medical condition in easily understood language |
GastroEnteroPancreatic NeuroEndocrine Tumours (GEP-NET's) |
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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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062476 |
E.1.2 | Term | Neuroendocrine tumor |
E.1.2 | System Organ Class | 100000004864 |
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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 |
Comparison of diagnostic results obtained with the departments routine investigation for GEP-NETs performed with 111In-Octrotide SPECT-CT to a newly developed method using 68Ga-DOTATATE for PET-CT. The main purpose is to evaluate if the PET-CT method is at least as effective as the routine method with SPECT-CT. |
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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 referred to the Department of Gastroenterology (dep. S), Odense University Hospital, with suspected GEP-NETs, will at their first appointment receive information about the clinical trial. Formal decision to participate may be made in relation to this information or by response to one of the involved physicians at Dept. S within 48 hours of having received the information. If the patient decides to participate, randomization is performed by the clinical physician at Dept. S to either the 111In-Octreotide SPECT-CT or 68Ga-DOTATATE PET-CT with the second examination to be performed within four weeks of the initial examination but with at least five days between the two examinations and prior to possible scheduled surgery. The physician performing the randomization sends a request to the Department of Nuclear Medicine (DNM), Odense University Hospital for both investigations with specification of the sequence as determined by the randomization. The patient is requested to bring the signed consent form when attending for the initial examination. To secure an even distribution between the sequence of the two imaging modalities throughout the trial, the patients are randomized in bulks of 2 and 2 with regards to either the 111In-Octreotide SPECT-CT or 68Ga-DOTATATE PET-CT being the initial examination.
Patients are included only after written and oral information is given followed by the patients’ signed consent.
Fertile women must on each examination day produce a negative pregnancy test prior to injection of the radiopharmaceuticals to remain included in the study.
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E.4 | Principal exclusion criteria |
Patients below 18 years of age, pregnant or nursing, unwilling, or unable to comply with the protocol or patients with hypersensitivity to any of the substances in the pharmaceuticals are excluded. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of 111In-Octrotide SPECT-CT to 68Ga-DOTATATE for PET-CT. Each examination is reported in the daily routine in the department and sent to the referring party as usual (primary evaluation). In this procedure each examination is reported by two separate nuclear medicine physicians responsible for the routine reporting of such examinations and with at least one having senior nuclear medicine expertise and experience in reading this type of examinations.
The following trial-based evaluation (secondary evaluation) after the routine report is performed by a few selected physicians blinded to the set of images from the complementary examination, but not to information from other imaging modalities. The selected physicians for the secondary evaluation are not allowed to report examinations in the daily routine of included patients. In the secondary evaluation the same physicians are not allowed to describe both examinations of the same patient.
Primary endpoint:
a) a pathological finding divided into five categories;
1) no pathology 2) predominantly no pathology 3) intermediate risk of pathology 4) predominantly certain pathology 5) certain pathology
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the imaging results is performed continuously |
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E.5.2 | Secondary end point(s) |
Secondary endpoints:
b) Is the finding a primary tumour or metastasis?
c) Organs involved.
d) Metastases per organ divided into four categories;
1) 1 metastasis 2) 2-3 metastases 3) 4-5 metastases 4) > 5 metastases
e) Pathological findings during a 1-year follow-up period based on clinical evaluation as well as other diagnostic modalities.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the imaging results is performed continuously |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |