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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heikki Minn, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01460706
First received: October 25, 2011
Last updated: December 11, 2013
Last verified: December 2013
  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: 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 Turku University Hospital:

Primary Outcome Measures:
  • Malignant glioma uptake of 68Ga-DOTATOC [ Time Frame: within 90 minutes post-injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Heikki Minn, Chief Physician, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01460706     History of Changes
Other Study ID Numbers: 77/180/2010
Study First Received: October 25, 2011
Last Updated: December 11, 2013
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by 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
Edotreotide
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014