uPAR-PET/MRI in Glioblastoma Multiforme

Glioblastoma Multiforme Clinical Trial

Official title:

uPAR-PET/MRI in Glioblastoma Multiforme

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02945826
• Other study ID #: AK2016-2
• Secondary ID: 2016-002417-21
• Status: Recruiting
• Phase: Phase 2
• First received: October 25, 2016
• Last updated: April 9, 2018
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: April 2018
• Source: Rigshospitalet, Denmark
• Contact: Dorthe Skovgaard, MD, PhD
• Phone: +4561274706
• Email: dskovgaard[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• One injection of 68Ga-NOTA-AE105
One injection of 68Ga-NOTA-AE105

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

Locations

Country	Name	City	State
Denmark	Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	uPAR PET/MRI prognostic factor for overall survival	Patients will be followed for 36 months after uPAR/PET MRI	36 months
Secondary	uPAR PET/MRI prognostic factor for progression free survival	Patients will be followed for 36 months	36 months