Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT (DOTAGLI)

Turku University Hospital (TYKS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Glioma

Treatments: Drug: [68Ga]DOTATOC

Study type: Interventional

Funder types: Other

Identifiers

NCT01460706

77/180/2010

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

68Ga-DOTATOC

Experimental group

Treatment:

Drug: [68Ga]DOTATOC