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uPAR-PET/MRI in Glioblastoma Multiforme

uPAR-PET/MRI in Glioblastoma Multiforme

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02945826
Enrollment
35
Registered
2016-10-26
Start date
2017-01-31
Completion date
2020-12-31
Last updated
2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Keywords

urokinase plasminogen activator receptor, positron emission tomography, glioblastoma multiforme

Brief summary

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

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

Interventions

One injection of 68Ga-NOTA-AE105

DEVICEPET/MRI

Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
uPAR PET/MRI imaging of uPAR expression1 hourStandard 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)
uPAR PET/MRI prognostic factor for overall survival36 monthsPatients will be followed for 36 months after uPAR/PET MRI

Secondary

MeasureTime frameDescription
uPAR PET/MRI prognostic factor for progression free survival36 monthsPatients will be followed for 36 months

Countries

Denmark

Contacts

Primary ContactDorthe Skovgaard, MD, PhD
dskovgaard@dadlnet.dk+4561274706
Backup ContactKjaer Andreas, professor
akjaer@sund.ku.dk+4535454011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026