uPAR-PET/MRI in Glioblastoma Multiforme

April 9, 2018 updated by: Dorthe Skovgaard, Rigshospitalet, Denmark
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: uPAR PET/MRI
One injection of 68Ga-NOTA-AE105 followed by PET/MRI.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uPAR PET/MRI imaging of uPAR expression
Time Frame: 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)
1 hour
uPAR PET/MRI prognostic factor for overall survival
Time Frame: 36 months
Patients will be followed for 36 months after uPAR/PET MRI
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uPAR PET/MRI prognostic factor for progression free survival
Time Frame: 36 months
Patients will be followed for 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Dorthe Skovgaard, Md, PhD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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