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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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.

Detailed Summary:

Background

Neuroendocrine tumors Neuroendocrine tumors (NET) are heterogeneous slow-growing neoplasms, occurring in 1-4/100,000 people per year. They origin from endocrine cells that derive from entodermal stem cells and are characterized by an endocrine metabolism and a typical pathologic pattern.

Slow metabolic rates of NET, small lesion size and variable anatomical localization have represented the major limits for lesions diagnosis. The diagnostic workup for NET has relied on conventional morphological imaging procedures including computed tomography (CT), ultrasound (US) and magnetic resonance imaging (MRI) combined with gamma camera functional imaging, namely whole-body somatostatin receptor scintigraphy (SRS). SRS show a higher diagnostic accuracy than CT for NET diagnosis at both the primary and metastatic site, but there is still room for improvement. Novel PET tracers specifically developed for NET may increase diagnostic accuracy considerably as outlined below.

Somatostatin receptor scintigraphy (SRS) As NET have high affinity somatostatin receptors, scintigraphic methods have been developed in the early nineties to allow in vivo imaging. SRS using Indium-111-DTPA-octreotide (Indium-111-pentetreotide scintigraphy), is the most widely used diagnostic test. Although rather sensitive and helpful for whole body staging compared to traditional imaging methods, this technique has pitfalls, one of them being the poor spatial resolution, leading to the development of PET-based imaging.

Gallium-68-DOTA-peptide PET In the past decade, several positron emitting tracers have been developed for NET imaging. 68Ga-DOTA-peptides are a group of PET tracers that specifically bind to somatostatin receptors (SSTR) over-expressed on N
Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome:

  • Number of patients correctly identified as having GEP-NET by using Gallium-68-DOTATATE PET/CT and Indium-111-pentetreotide scintigraphy (SPECT/CT) [ Time Frame: 6 months ]
  • Number of patients correctly identified as not having GEP-NET by using Gallium-68-DOTATATE PET/CT and Indium-111-pentetreotide scintigraphy (SPECT/CT) [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient satisfaction [ Time Frame: 6 months ]
    Measured by patient satisfaction questionnaire relating to Indium-111-pentetreotide scintigraphy
  • Number of patients with adverse events [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: University Hospital Inselspital, Berne

Dates:
Date Received: February 26, 2014
Date Started: March 2014
Date Completion:
Last Updated: September 5, 2016
Last Verified: September 2016