uPAR-PET/MRI in Glioblastoma Multiforme

Phase 2

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: One injection of 68Ga-NOTA-AE105; Device: PET/MRI

• Registration Number: NCT02945826
• Lead Sponsor: Rigshospitalet, Denmark

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

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-26
• Study Start: 2017-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-10
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
uPAR PET/MRI	One injection of 68Ga-NOTA-AE105	One injection of 68Ga-NOTA-AE105 followed by PET/MRI.
uPAR PET/MRI	PET/MRI	One injection of 68Ga-NOTA-AE105 followed by PET/MRI.

Primary Outcome Measures

Name	Time	Method
uPAR PET/MRI prognostic factor for overall survival	36 months	Patients will be followed for 36 months after uPAR/PET MRI
uPAR PET/MRI imaging of uPAR expression	1 hour	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)

Secondary Outcome Measures

Name	Time	Method
uPAR PET/MRI prognostic factor for progression free survival	36 months	Patients will be followed for 36 months

Trial Locations

Locations (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet; 🇩🇰 Copenhagen, Denmark