TheranosticTrials.org

Clinical Trial · NCT02078843

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

Overview

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.

Sponsor

Insel Gruppe AG, University Hospital Bern

Phase

Phase 1/2

Contacts

Thomas Krause, Prof. Dr. med. (PRINCIPAL_INVESTIGATOR)

Christoph Stettler, Prof. Dr. med. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02078843

Drug / Compound

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

pentetreotide

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DTPA

Eligibility

Inclusion

  • 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
  • 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
  • Inclusion criteria specific for controls only
  • Patient referred to Indium-111-pentetreotide scintigraphy., which was performed as part of clinical routine care
  • Histologically established GEP-NET (new or recurrent)
  • Tumor mass remaining after initial biopsy or surgery
  • Patients for whom it remains unclear whether the tumor was completely removed
  • Inclusion criteria specific for cases only
  • 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 surgeryExclusion Criteria
  • Pregnant or nursing women

Exclusion

Exclusion criteria not yet provided.