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

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ClinicalTrials.gov Identifier: NCT01460706

Recruitment Status : Completed

First Posted : October 27, 2011

Last Update Posted : December 12, 2013

Sponsor:

Information provided by (Responsible Party):

Heikki Minn, Turku University Hospital

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.

Condition or disease	Intervention/treatment	Phase
Glioma	Drug: [68Ga]DOTATOC	Phase 2 Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	PET/CT Imaging of Malignant Glioma With Somatostatin Analog 68Ga-DOTATOC
Study Start Date :	October 2011
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diagnostic Imaging

Genetic and Rare Diseases Information Center resources: Glioma Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460706

Locations


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

Sponsors and Collaborators

Turku University Hospital

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kiviniemi A, Gardberg M, Frantzén 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.


Responsible Party:	Heikki Minn, Chief Physician, Turku University Hospital
ClinicalTrials.gov Identifier:	NCT01460706 History of Changes
Other Study ID Numbers:	77/180/2010
First Posted:	October 27, 2011 Key Record Dates
Last Update Posted:	December 12, 2013
Last Verified:	December 2013

Keywords provided by Heikki Minn, Turku University Hospital:


Glioma 68Ga-DOTATOC PET/CT Somatostatin receptor

Additional relevant MeSH terms:


Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Somatostatin Edotreotide	Octreotide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents Antineoplastic Agents, Hormonal Antineoplastic Agents

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