Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

NCT01460706 — Phase 2 / Phase 3, Completed, 30 participants, Turku University Hospital

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

Registry	NCT01460706, acronym DOTAGLI
Status	Completed
Phase	Phase 2 / Phase 3
Study type	Interventional; non randomized, single group, masking: none, basic science
Enrollment	30 (Actual)
Sponsor	Turku University Hospital (Other gov)
Conditions	Glioma
Interventions	[68Ga]DOTATOC (Drug)
Dates	start 2011-10-01, primary completion 2013-12-01, completion 2013-12-01, first posted 2011-10-27, last updated 2013-12-12
Locations	1 site in Finland

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
68Ga-DOTATOC	Experimental	Drug: [68Ga]DOTATOC

[68Ga]DOTATOC (Drug): 120MBq 68Ga-DOTATOC intravenously and PET/CT imaging. Performed once to a patient before the surgery.

+Outcome measures

Primary outcomes

Malignant glioma uptake of 68Ga-DOTATOC [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 outcomes

Immunohistochemical SST2 receptor status of the tumor specimen [After glioma surgery within 4 weeks of PET/CT imaging]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Turku PET Centre, Turku University Hospital	Turku	Finland

+Publications

Results publication: Kiviniemi A, Gardberg M, Frantzen J, Pesola M, Vuorinen V, Parkkola R, Tolvanen T, Suilamo S, Johansson J, Luoto P, Kemppainen J, Roivainen A, Minn H. Somatostatin receptor subtype 2 in high-grade gliomas: PET/CT with (68)Ga-DOTA-peptides, correlation to prognostic markers, and implications for targeted radiotherapy. EJNMMI Res. 2015 Apr 22;5:25. doi: 10.1186/s13550-015-0106-2. eCollection 2015. PMID 25977882

+Investigators

Heikki RI Minn, M.D., Ph.D., Principal investigator, Turku University Hospital

My Notes

Public

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