Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

NCT ID: NCT01460706

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Glioma

Keywords

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Glioma 68Ga-DOTATOC PET/CT Somatostatin receptor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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68Ga-DOTATOC

Group Type EXPERIMENTAL

[68Ga]DOTATOC

Intervention Type DRUG

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

Interventions

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[68Ga]DOTATOC

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Heikki Minn

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Turku PET Centre, Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 25977882 (View on PubMed)

Other Identifiers

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77/180/2010

Identifier Type: -

Identifier Source: org_study_id