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PET/CT Imaging of Malignant Glioma With Somatostatin Analog 68Ga-DOTATOC


Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Glioma

Thank you

Trial Information

PET/CT Imaging of Malignant Glioma With Somatostatin Analog 68Ga-DOTATOC


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Malignant glioma uptake of 68Ga-DOTATOC

Outcome Description:

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.

Outcome Time Frame:

within 90 minutes post-injection

Safety Issue:

No

Principal Investigator

Heikki RI Minn, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Turku University Hospital

Authority:

Finland: Ethics Committee

Study ID:

77/180/2010

NCT ID:

NCT01460706

Start Date:

October 2011

Completion Date:

December 2013

Related Keywords:

  • Glioma
  • Glioma
  • 68Ga-DOTATOC
  • PET/CT
  • Somatostatin receptor
  • Glioma

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