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Trial record 21 of 1110 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Approved for marketing Studies | glioblastoma

uPAR-PET/MRI in Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02945826
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : April 10, 2018
Information provided by (Responsible Party):
Dorthe Skovgaard, 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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: One injection of 68Ga-NOTA-AE105 Device: PET/MRI Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: uPAR-PET/MRI in Glioblastoma Multiforme
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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)

  2. uPAR PET/MRI prognostic factor for overall survival [ Time Frame: 36 months ]
    Patients will be followed for 36 months after uPAR/PET MRI

Secondary Outcome Measures :
  1. uPAR PET/MRI prognostic factor for progression free survival [ Time Frame: 36 months ]
    Patients will be followed for 36 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02945826

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Contact: Dorthe Skovgaard, MD, PhD +4561274706
Contact: Kjaer Andreas, professor +4535454011

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Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Dorthe Skovgaard, MD, Phd    +4561274706   
Contact: Andreas Kjaer, Professor    +4535454011   
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Dorthe Skovgaard, Md, PhD Rigshospitalet, Denmark

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Responsible Party: Dorthe Skovgaard, Principal investigator, MD, Phd, Rigshospitalet, Denmark Identifier: NCT02945826     History of Changes
Other Study ID Numbers: AK2016-2
2016-002417-21 ( EudraCT Number )
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dorthe Skovgaard, Rigshospitalet, Denmark:
urokinase plasminogen activator receptor
positron emission tomography
glioblastoma multiforme
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue