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uPAR-PET/MRI in Glioblastoma Multiforme

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Rigshospitalet

Status and phase

Unknown
Phase 2

Conditions

Glioblastoma Multiforme

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02945826
2016-002417-21 (EudraCT Number)
AK2016-2

Details and patient eligibility

About

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.

Full 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

Enrollment

35 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

uPAR PET/MRI
Experimental group
Description:
One injection of 68Ga-NOTA-AE105 followed by PET/MRI.
Treatment:
Device: PET/MRI
Drug: One injection of 68Ga-NOTA-AE105

Trial contacts and locations

1

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Central trial contact

Dorthe Skovgaard, MD, PhD; Kjaer Andreas, professor

Data sourced from clinicaltrials.gov

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