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

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ClinicalTrials.gov Identifier: NCT01460706
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):
Heikki Minn, Turku University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Glioma Drug: [68Ga]DOTATOC Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 68Ga-DOTATOC Drug: [68Ga]DOTATOC
120MBq 68Ga-DOTATOC intravenously and PET/CT imaging. Performed once to a patient before the surgery.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Immunohistochemical SST2 receptor status of the tumor specimen [ Time Frame: After glioma surgery within 4 weeks of PET/CT imaging ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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
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Finland
Turku PET Centre, Turku University Hospital
Turku, Finland, FI-21100
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Heikki RI Minn, M.D., Ph.D. Turku University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Heikki Minn, Chief Physician, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01460706    
Other Study ID Numbers: 77/180/2010
First Posted: October 27, 2011    Key Record Dates
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:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Edotreotide
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action