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.
Conditions
Interventions
Product Name: 68Ga-DOTATOC
Product Code: 68Ga-DOTATOC
Pharmaceutical Form: Injection
INN or Proposed INN: OCTREOTIDE
CAS Number: 83150-76-9
Current Sponsor code: 68Ga-DOTATOC
Other descriptive name: 6
Sponsors
Medizinische Universität Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of this proposed study is to compare the accuracy of MRI and 68Ga-DOTATOC-PET for primary diagnosis and assessment of residual tumor after surgery, their value for follow up visits and to diagnose tumor progression. ;Secondary Objective: As a secondary study objective, a direct comparison between SSTR2 expression in tumor tissue and 68Ga-DOTATOC uptake as well as immunhistochemical analysis of other biologically relevant hormone and growth factor receptors will be investigated with regard to improve diagnosis and treatment planning of meningiomas. Additionally, the tumor volumes in cerebral MRI sequences using contrast agent and metabolic tumor volumes in 68Ga-DOTATOC PET will be measured. Following this, overlap analysis of the measured volumes will be performed.;Primary end point(s): Determination of diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) as well as signal activity of cerebral MRI T1 sequences using contrast agent (contrast enhancement, CE) and 68Ga-DOTATOC-PET (Standardized Uptake Values, SUV) prior and post surgery and follow up visits;Timepoint(s) of evaluation of this end point: Evaluation of the primary end point will be performed after last study patient has finished Follow Up Visite 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Correlation between metabolic activity of 68Ga-DOTATOC-PET (Standardized Uptake Values; SUV) and immunohistochemical SSTR analysis for quantitative assessment of receptor densitiy (immunoreactive score; IRS) as well as determination of Cut-off-values Comparison of measured tumor volumes (cm3) in MRI T1 sequences and metabolic tumor volumes in 68Ga-DOTATOC-PET pre- and postoperative as well as follow up followed by overlap analysis (Dice coefficient;Timepoint(s) of evaluation of this end point: Correlation analyses will be performed after the last study patient has undergone surgery (Study Visite 2) Comparison of measured tumor volumes will be performed, after last study patient has finished Follow Up Visite 2. | — |
Countries
Austria
Contacts
Public ContactMedizinische Universität Innsbruck
Medizinische Universität Innsbruck
Outcome results
None listed