Imaging with 111In-Octreotide SPECT-CT compared to 68Ga-DOTATATE PET-CT in patients admitted for evaluation of GastroEnteroPancreatic NeuroEndocrine Tumours, GEP-NETs

Phase 1

• Conditions: GastroEnteroPancreatic NeuroEndocrine Tumours (GEP-NET's); MedDRA version: 17.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2013-001807-35-DK
• Lead Sponsor: Department of Nuclear Medicine, Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-22
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified