uPAR-PET/MRI in Glioblastoma Multiforme

Study Overview
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Brief Summary
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The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / MRI molecular imaging of glioblastoma.

Detailed Description
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68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/MRI will be applied in patients suspected of glioblastoma multiforme. The uptake of the radioligand 68Ga-NOTA-AE105 will be compared and correlated with expression of the molecular target: uPAR using immunohistochemistry of tumor tissue samples obtained during routine stereotactic biopsies or operation. In addition, the semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in tumor tissue will be correlated with overall survival and progression free survival

Official Title
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uPAR-PET/MRI in Glioblastoma Multiforme

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Drug: One injection of 68Ga-NOTA-AE105
* Device: PET/MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients where imaging with MRI or CT is suspicious of having glioblastoma multiforme, and patients, and who is referred for stereotactic biopsy, chemotherapy or surgery The participants must be capable of understanding and giving full informed written consent age above 18 years Exclusion Criteria: Pregnancy Lactation/breast feeding Age above 85 years old Weight above 140 kg Known allergy towards 68Ga-NOTA-AE105

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: uPAR PET/MRI<br>One injection of 68Ga-NOTA-AE105 followed by PET/MRI. | Drug: One injection of 68Ga-NOTA-AE105<br>* One injection of 68Ga-NOTA-AE105<br>Device: PET/MRI<br>* Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uPAR PET/MRI imaging of uPAR expression | Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/MRI scan performed within 1 hour following injection of 68Ga-NOTA-AE105, compared with immunohistochemistry of uPAR (semiquantitative) | 1 hour | 
| uPAR PET/MRI prognostic factor for overall survival | Patients will be followed for 36 months after uPAR/PET MRI | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uPAR PET/MRI prognostic factor for progression free survival | Patients will be followed for 36 months | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urokinase plasminogen activator receptor, positron emission tomography, glioblastoma multiforme