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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

Arms and Interventions

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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

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Primary Outcome Measures :

1. 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 :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
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

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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

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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
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