Investigation to understand the significance of a new nuclear medicine imaging technique (68Ga-DOTAOTC PET) for diagnosis of newly diagnosed or recurrent brain tumors originating in the arachnoid membrane (meningiomas)

Conditions: Based on the finding that meningiomas express somatostatin-receptor 2 (SSTR2), PET imaging with SSTR ligands like 68Ga-DOTATOC has been proposed as a more specific method. Currently, the role of SSTR-based imaging for meningioma diagnosis and treatment is still unclear. Therefore the accuracy of MRI and 68Ga-DOTATOC-PET for meningioma diagnosis at initial presentation, to determine residual tumor postoperatively and recurrence during follow-up will be investigated.
Therapeutic area: Not possible to specify

Registration Number: EUCTR2013-002526-23-AT

Lead Sponsor: Medizinische Universität Innsbruck

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- The patient must be = 18 years and = 75 of age
- MRI with suspicion of meningeal tumor and imperative necessity of resection
OR
MRI with confirmation of progressive disease of known and histological verified meningeal tumor (ICD-codes D32.0 and C70.0) and imperative necessity of resection
- The patient must have an ECOG performance status 0-2
- Signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Anamnestic known hypersensitivity or side effects of accomplished 68Ga-DOTATOC-PET prior to study enrollment
- ECOG >2
- The patient is active participant in another clinical trial, which investigates diagnostic and treatment of meningeal tumors
- Other severe acute or chronic medical or psychiatric condition that would impart excess risk associated with study participation or which would make the patient inappropriate for entry into this study. The decision to enroll the patient in this study is in the judgment of the investigator
- Pregnancy and Breastfeeding:
Female patients who are pregnant or nursing
- Evidence of incompliance of the patient to not comply with scheduled visits, treatment plans, laboratory test and other study procedures
- Prior therapy with Octreotid or prior chemotherapy/local radiotherapy within the last 4 weeks