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

Primary Purpose

Glioma

Status

Completed

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

[68Ga]DOTATOC

About this trial

This is an interventional basic science trial for Glioma focused on measuring Glioma, 68Ga-DOTATOC, PET/CT, Somatostatin receptor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Turku PET Centre, Turku University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-DOTATOC

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Immunohistochemical SST2 receptor status of the tumor specimen

Full Information

NCT ID

NCT01460706

First Posted

October 25, 2011

Last Updated

December 11, 2013

Sponsor

Turku University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01460706

Brief Title

Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

Acronym

DOTAGLI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Turku University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

68Ga-DOTATOC

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

[68Ga]DOTATOC

Intervention Description

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

Primary Outcome Measure Information:

Title

Malignant glioma uptake of 68Ga-DOTATOC

Description

Time Frame

within 90 minutes post-injection

Secondary Outcome Measure Information:

Title

Immunohistochemical SST2 receptor status of the tumor specimen

Time Frame

After glioma surgery within 4 weeks of PET/CT imaging

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heikki RI Minn, M.D., Ph.D.

Organizational Affiliation

Turku University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Turku PET Centre, Turku University Hospital

City

Turku

ZIP/Postal Code

FI-21100

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

25977882

Citation

Kiviniemi A, Gardberg M, Frantzen J, Pesola M, Vuorinen V, Parkkola R, Tolvanen T, Suilamo S, Johansson J, Luoto P, Kemppainen J, Roivainen A, Minn H. Somatostatin receptor subtype 2 in high-grade gliomas: PET/CT with (68)Ga-DOTA-peptides, correlation to prognostic markers, and implications for targeted radiotherapy. EJNMMI Res. 2015 Apr 22;5:25. doi: 10.1186/s13550-015-0106-2. eCollection 2015.

Results Reference

derived

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Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

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