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

NCT02078843 | Terminated Phase 1

• 1 other identifier: 092/11
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Keywords

NET; Gallium-68-DOTATATE; PET/CT; Indium-111-pentetreotide scintigraphy; octreoscan; GEP-NET; gastroenteropancreatic neuroendocrine tumors

Outcome Measures

Primary Outcomes (2)

• Number of patients correctly identified as having GEP-NET by using Gallium-68-DOTATATE PET/CT and Indium-111-pentetreotide scintigraphy (SPECT/CT)

  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)

  6 months

Secondary Outcomes (2)

• Patient satisfaction

  6 months

• Number of patients with adverse events

  6 months

Study Arms (1)

All patients

OTHER

Subsequent performance of index test and standard test

Drug: Gallium-68-DOTATATE PET/CT (index test); Drug: Indium-111-Octreoscan (standard test)

Interventions

Gallium-68-DOTATATE PET/CT (index test) DRUG

Somatostatin-based imaging tracer

All patients

Indium-111-Octreoscan (standard test) DRUG

Somatostatin-based imaging tracer

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Histologically established GEP-NET (new or recurrent)
• Tumor mass remaining after initial biopsy or surgery
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Lausanne Hospitals: collaborator
• University Hospital, Basel, Switzerland: collaborator
• University of Bern: collaborator
• SWAN Isotopen AG, Bern: collaborator

Study Sites (1)

Nuclear Medicine, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (5)

• Gabriel M, Oberauer A, Dobrozemsky G, Decristoforo C, Putzer D, Kendler D, Uprimny C, Kovacs P, Bale R, Virgolini IJ. 68Ga-DOTA-Tyr3-octreotide PET for assessing response to somatostatin-receptor-mediated radionuclide therapy. J Nucl Med. 2009 Sep;50(9):1427-34. doi: 10.2967/jnumed.108.053421. Epub 2009 Aug 18.

  PMID: 19690033 BACKGROUND

• Putzer D, Gabriel M, Henninger B, Kendler D, Uprimny C, Dobrozemsky G, Decristoforo C, Bale RJ, Jaschke W, Virgolini IJ. Bone metastases in patients with neuroendocrine tumor: 68Ga-DOTA-Tyr3-octreotide PET in comparison to CT and bone scintigraphy. J Nucl Med. 2009 Aug;50(8):1214-21. doi: 10.2967/jnumed.108.060236. Epub 2009 Jul 17.

  PMID: 19617343 BACKGROUND

• Antunes P, Ginj M, Zhang H, Waser B, Baum RP, Reubi JC, Maecke H. Are radiogallium-labelled DOTA-conjugated somatostatin analogues superior to those labelled with other radiometals? Eur J Nucl Med Mol Imaging. 2007 Jul;34(7):982-93. doi: 10.1007/s00259-006-0317-x. Epub 2007 Jan 16.

  PMID: 17225119 BACKGROUND

• Reubi JC, Schar JC, Waser B, Wenger S, Heppeler A, Schmitt JS, Macke HR. Affinity profiles for human somatostatin receptor subtypes SST1-SST5 of somatostatin radiotracers selected for scintigraphic and radiotherapeutic use. Eur J Nucl Med. 2000 Mar;27(3):273-82. doi: 10.1007/s002590050034.

  PMID: 10774879 BACKGROUND

• Srirajaskanthan R, Kayani I, Quigley AM, Soh J, Caplin ME, Bomanji J. The role of 68Ga-DOTATATE PET in patients with neuroendocrine tumors and negative or equivocal findings on 111In-DTPA-octreotide scintigraphy. J Nucl Med. 2010 Jun;51(6):875-82. doi: 10.2967/jnumed.109.066134. Epub 2010 May 19.

  PMID: 20484441 BACKGROUND

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor

Study Officials

• Thomas Krause, Prof. Dr. med.

  Institute of Nuclear Medicine, University Hospital Berne

  PRINCIPAL INVESTIGATOR

• Christoph Stettler, Prof. Dr. med.

  Division of Endocrinology, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 5, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

CH (1)