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Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT (DOTAGLI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01460706
First Posted: October 27, 2011
Last Update Posted: December 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Heikki Minn, Turku University Hospital
  Purpose
The purpose of this study is to characterize tumour uptake of somatostatin analog 68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status of the tumor specimen.

Condition Intervention Phase
Glioma Drug: [68Ga]DOTATOC Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: PET/CT Imaging of Malignant Glioma With Somatostatin Analog 68Ga-DOTATOC

Resource links provided by NLM:


Further study details as provided by Heikki Minn, Turku University Hospital:

Primary Outcome Measures:
  • Malignant glioma uptake of 68Ga-DOTATOC [ Time Frame: within 90 minutes post-injection ]
    PET/CT imaging of the brain starts immediately after the intravenous bolus injection of 68Ga-DOTATOC. Dynamic PET/CT imaging is done over 60-min. A late 90-min scan will be obtained for selected patients. PET studies are analyzed by determining the Standardized Uptake Values (SUV) of the tumor using regions of interest (ROI) drawn both manually and automatically on the tumor.


Secondary Outcome Measures:
  • Immunohistochemical SST2 receptor status of the tumor specimen [ Time Frame: After glioma surgery within 4 weeks of PET/CT imaging ]

Enrollment: 30
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 68Ga-DOTATOC Drug: [68Ga]DOTATOC
120MBq 68Ga-DOTATOC intravenously and PET/CT imaging. Performed once to a patient before the surgery.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 to 70 years old
  • Language spoken: Finnish or Swedish
  • Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
  • Supratentorial malignant glioma based on MRI imaging
  • Supratentorial recurrent glioma based on MRI and/or [11C]methionine PET imaging
  • Patients must be able to understand the meaning of the study and sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

  • Any medical or psychiatric condition that compromises the subject´s ability to participate in the study
  • Any other significant disease including liver or renal disease
  • Pregnant or lactating women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460706


Locations
Finland
Turku PET Centre, Turku University Hospital
Turku, Finland, FI-21100
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Heikki RI Minn, M.D., Ph.D. Turku University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heikki Minn, Chief Physician, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01460706     History of Changes
Other Study ID Numbers: 77/180/2010
First Submitted: October 25, 2011
First Posted: October 27, 2011
Last Update Posted: December 12, 2013
Last Verified: December 2013

Keywords provided by Heikki Minn, Turku University Hospital:
Glioma
68Ga-DOTATOC
PET/CT
Somatostatin receptor

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Somatostatin
Edotreotide
Octreotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents