Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT

Glioma Clinical Trial

— DOTAGLI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460706
• Other study ID #: 77/180/2010
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 25, 2011
• Last updated: December 11, 2013
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glioma

Intervention

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

Locations

Country	Name	City	State
Finland	Turku PET Centre, Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Immunohistochemical SST2 receptor status of the tumor specimen		After glioma surgery within 4 weeks of PET/CT imaging	No