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uPAR-PET/MRI in Glioblastoma Multiforme

Primary Purpose

Glioblastoma Multiforme

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
One injection of 68Ga-NOTA-AE105
PET/MRI
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma Multiforme focused on measuring urokinase plasminogen activator receptor, positron emission tomography, glioblastoma multiforme

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinical Physiology, Nuclear Medicine and PET, RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

uPAR PET/MRI

Arm Description

One injection of 68Ga-NOTA-AE105 followed by PET/MRI.

Outcomes

Primary Outcome Measures

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)
uPAR PET/MRI prognostic factor for overall survival
Patients will be followed for 36 months after uPAR/PET MRI

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2016
Last Updated
April 9, 2018
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02945826
Brief Title
uPAR-PET/MRI in Glioblastoma Multiforme
Official Title
uPAR-PET/MRI in Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
urokinase plasminogen activator receptor, positron emission tomography, glioblastoma multiforme

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
uPAR PET/MRI
Arm Type
Experimental
Arm Description
One injection of 68Ga-NOTA-AE105 followed by PET/MRI.
Intervention Type
Drug
Intervention Name(s)
One injection of 68Ga-NOTA-AE105
Intervention Description
One injection of 68Ga-NOTA-AE105
Intervention Type
Device
Intervention Name(s)
PET/MRI
Intervention Description
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain
Primary Outcome Measure Information:
Title
uPAR PET/MRI imaging of uPAR expression
Description
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)
Time Frame
1 hour
Title
uPAR PET/MRI prognostic factor for overall survival
Description
Patients will be followed for 36 months after uPAR/PET MRI
Time Frame
36 months
Secondary Outcome Measure Information:
Title
uPAR PET/MRI prognostic factor for progression free survival
Description
Patients will be followed for 36 months
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorthe Skovgaard, MD, PhD
Phone
+4561274706
Email
dskovgaard@dadlnet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Kjaer Andreas, professor
Phone
+4535454011
Email
akjaer@sund.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorthe Skovgaard, Md, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorthe Skovgaard, MD, Phd
Phone
+4561274706
Email
dskovgaard@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Andreas Kjaer, Professor
Phone
+4535454011
Email
akjaer@sund.ku.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

uPAR-PET/MRI in Glioblastoma Multiforme

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