Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

NCT01460706 | Completed Phase 2 DMC

• 1 other identifier: 77/180/2010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  within 90 minutes post-injection

Secondary Outcomes (1)

• Immunohistochemical SST2 receptor status of the tumor specimen

  After glioma surgery within 4 weeks of PET/CT imaging

Study Arms (1)

68Ga-DOTATOC

EXPERIMENTAL

Drug: [68Ga]DOTATOC

Interventions

[68Ga]DOTATOC DRUG

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

68Ga-DOTATOC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku PET Centre, Turku University Hospital

Turku, FI-21100, Finland

Location

Related Publications (1)

• 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.

  PMID: 25977882 DERIVED

MeSH Terms

Conditions

Glioma

Interventions

Ga(III)-DOTATOC

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Heikki RI Minn, M.D., Ph.D.

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 27, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

FI (1)