Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesize that the new imaging method Gallium-68-DOTATATE has a higher diagnostic value in the detection of neuroendocrine tumors than the established imaging method Indium-111-Octreoscan. Therefore, the investigators will perform both imaging procedures in patients with suspected or confirmed neuroendocrine tumors. Subsequently, the investigators will compare the diagnostic performance of both methods.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: SWAN Isotopen AG, Bern; University Hospital, Basel, Switzerland; University of Bern; University of Lausanne Hospitals
• Treatments: Somatostatin

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Signed written informed consent with full understanding of the study procedures and the investigational nature of the study

• Patient referred to Indium-111-pentetreotide scintigraphy., which was performed as part of clinical routine care

• Inclusion criteria specific for cases only

• Histologically established GEP-NET (new or recurrent)

• Tumor mass remaining after initial biopsy or surgery

• Inclusion criteria specific for controls only

• 5.6. Suspicion of any NET (new or recurrent) but no established diagnosis or established diagnosis of any NET (new or recurrent) but no remaining tumor mass after surgery

Exclusion Criteria

• Previous inclusion in the same study with the following exception: a patient may be included as case if she/he was previously included as control

• Gastric type 2 ECL cell neuroendocrine tumors

• Pregnant or nursing women

• Known intolerance to any protocol required diagnostic intervention

• Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly

• Exclusion criteria specific for controls only

• Patients for whom it remains unclear whether the tumor was completely removed