Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

Study Overview
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Brief Summary
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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.

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

Conditions
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Glioma

Intervention / Treatment
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* Drug: [68Ga]DOTATOC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-DOTATOC<br> | Drug: [68Ga]DOTATOC<br>* 120MBq 68Ga-DOTATOC intravenously and PET/CT imaging. Performed once to a patient before the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malignant glioma uptake of 68Ga-DOTATOC | 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. | within 90 minutes post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunohistochemical SST2 receptor status of the tumor specimen |  | After glioma surgery within 4 weeks of PET/CT imaging | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioma, 68Ga-DOTATOC, PET/CT, Somatostatin receptor