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

December 11, 2013 updated by: Heikki Minn, Turku University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, FI-21100
        • Turku PET Centre, Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Heikki RI Minn, M.D., Ph.D., Turku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (Estimate)

October 27, 2011

Study Record Updates

Last Update Posted (Estimate)

December 12, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77/180/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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