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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioma | Drug: [68Ga]DOTATOC | Phase 2 Phase 3 |
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 |

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

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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 |
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

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
Finland | |
Turku PET Centre, Turku University Hospital | |
Turku, Finland, FI-21100 |
Principal Investigator: | Heikki RI Minn, M.D., Ph.D. | Turku University Hospital |
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 |
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