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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
University of Lausanne Hospitals
University Hospital, Basel, Switzerland
University of Bern
SWAN Isotopen AG, Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT02078843
First received: February 26, 2014
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Gastroenteropancreatic Neuroendocrine Tumors
Drug: Gallium-68-DOTATATE PET/CT (index test)
Drug: Indium-111-Octreoscan (standard test)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by patient satisfaction questionnaire relating to Indium-111-pentetreotide scintigraphy

  • Number of patients with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 133
Study Start Date: March 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All patients
Subsequent performance of index test and standard test
Drug: Gallium-68-DOTATATE PET/CT (index test)
Somatostatin-based imaging tracer
Drug: Indium-111-Octreoscan (standard test)
Somatostatin-based imaging tracer

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078843

Locations
Switzerland
Nuclear Medicine, l Bern University Hospita Recruiting
Bern, Switzerland, 3010
Contact: Martin A Walter, PD Dr.med    +416323542    martin.alexander.walter@gmail.com   
Contact: Nicolas D Marincek, Dr. med.    +410316328454    nicolas.marincek@insel.ch   
Principal Investigator: Thomas Krause, Prof. Dr. med         
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Lausanne Hospitals
University Hospital, Basel, Switzerland
University of Bern
SWAN Isotopen AG, Bern
Investigators
Principal Investigator: 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
  More Information

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02078843     History of Changes
Other Study ID Numbers: 092/11
Study First Received: February 26, 2014
Last Updated: March 18, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Federal Office of Public Health
Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
NET
Gallium-68-DOTATATE
PET/CT
Indium-111-pentetreotide scintigraphy
octreoscan
GEP-NET
gastroenteropancreatic neuroendocrine tumors

Additional relevant MeSH terms:
Neoplasms
Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 18, 2014