Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01460706

Acronym

DOTAGLI

Enrollment

Registered

2011-10-27

Start date

2011-10-31

Completion date

2013-12-31

Last updated

2013-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

Keywords

Glioma, 68Ga-DOTATOC, PET/CT, Somatostatin receptor

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.

Interventions

DRUG[68Ga]DOTATOC

120MBq 68Ga-DOTATOC intravenously and PET/CT imaging. Performed once to a patient before the surgery.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026