Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

Phase 2

Completed

• Conditions: Glioma
• Interventions: Drug: [68Ga]DOTATOC

• Registration Number: NCT01460706
• Lead Sponsor: Turku University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-27
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-DOTATOC	[68Ga]DOTATOC	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Immunohistochemical SST2 receptor status of the tumor specimen	After glioma surgery within 4 weeks of PET/CT imaging

Trial Locations

Locations (1)

Turku PET Centre, Turku University Hospital; 🇫🇮 Turku, Finland