GastroEnteroPancreatic NeuroEndocrine Tumours (GEP-NET's) MedDRA version: 17.0 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Octroscan
Product Name: NA
Product Code: NA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: OCTREOTIDE
CAS Number: 83150-76-9
Trade Name: 68Ga-DOTATATE is still in clinic
Sponsors
Department of Nuclear Medicine, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: Evaluation of the imaging results is performed continuously;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;Timepoint(s) of evaluation of this end point: Evaluation of the imaging results is performed continuously | — |
Countries
Denmark
Contacts
Public ContactJeppe Lauridsen
Department of Nuclear Medicine, Odense University Hospital
Outcome results
None listed