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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002417-21 | EudraCT Number |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| uPAR PET/MRI | Experimental | One injection of 68Ga-NOTA-AE105 followed by PET/MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One injection of 68Ga-NOTA-AE105 | Drug | One injection of 68Ga-NOTA-AE105 |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| uPAR PET/MRI prognostic factor for progression free survival | Patients will be followed for 36 months | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dorthe Skovgaard, MD, PhD | Contact | +4561274706 | dskovgaard@dadlnet.dk | |
| Kjaer Andreas, professor | Contact | +4535454011 | akjaer@sund.ku.dk |
| Name | Affiliation | Role |
|---|---|---|
| Dorthe Skovgaard, Md, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39472354 | Derived | Azam A, Kurbegovic S, Carlsen EA, Andersen TL, Larsen VA, Law I, Skjoth-Rasmussen J, Kjaer A. Prospective phase II trial of [68Ga]Ga-NOTA-AE105 uPAR-PET/MRI in patients with primary gliomas: Prognostic value and Implications for uPAR-targeted Radionuclide Therapy. EJNMMI Res. 2024 Oct 29;14(1):100. doi: 10.1186/s13550-024-01164-9. |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| PET/MRI |
| Device |
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain |
|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |