uPAR-PET/MRI in Glioblastoma Multiforme
2 other identifiers
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2016
CompletedFirst Posted
Study publicly available on registry
October 26, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 10, 2018
April 1, 2018
3.9 years
October 25, 2016
April 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
uPAR PET/MRI prognostic factor for progression free survival
36 months
Study Arms (1)
uPAR PET/MRI
EXPERIMENTALOne injection of 68Ga-NOTA-AE105 followed by PET/MRI.
Interventions
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Lactation/breast feeding
- Age above 85 years old
- Weight above 140 kg
- Known allergy towards 68Ga-NOTA-AE105
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (1)
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.
PMID: 39472354DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dorthe Skovgaard, Md, PhD
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, MD, Phd
Study Record Dates
First Submitted
October 25, 2016
First Posted
October 26, 2016
Study Start
January 1, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
April 10, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share