Glioblastoma MultiformePhase 2NCT02945826
uPAR-PET/MRI in Glioblastoma Multiforme
A Phase 2 study testing One injection of 68Ga-NOTA-AE105 and PET/MRI in people with Glioblastoma Multiforme, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- One injection of 68Ga-NOTA-AE105 and PET/MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2017to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Lactation/breast feeding
- Age above 85 years old
- Weight above 140 kg
- Known allergy towards 68Ga-NOTA-AE105
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, 2100
Dorthe Skovgaard, MD, Phd, +4561274706, dskovgaard@dadlnet.dk
Andreas Kjaer, Professor, +4535454011, akjaer@sund.ku.dk
About this study
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.
Read the 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
- Conditions
- Glioblastoma Multiforme
- Being tested
- One injection of 68Ga-NOTA-AE105, PET/MRI
- Keywords
- urokinase plasminogen activator receptor, positron emission tomography, glioblastoma multiforme
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One injection of 68Ga-NOTA-AE105Drug
One injection of 68Ga-NOTA-AE105
PET/MRIDevice
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain
| Study group | Role | What they receive |
|---|---|---|
| uPAR PET/MRI | Experimental | One injection of 68Ga-NOTA-AE105 followed by PET/MRI. Receives: Drug: One injection of 68Ga-NOTA-AE105; Device: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 hour
uPAR PET/MRI prognostic factor for overall survival
Patients will be followed for 36 months after uPAR/PET MRI
Measured: 36 months
Secondary outcomes (1)
uPAR PET/MRI prognostic factor for progression free survival
Patients will be followed for 36 months
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorthe Skovgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Dorthe Skovgaard, Md, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945826
- Sponsor's protocol ID
- AK2016-2
- Other IDs
- 2016-002417-21, 2016
- Status last verified
- Apr 2018
- First submitted
- 25 Oct 2016
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 39472354
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- uPAR-PET/MRI in Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT02945826
- Acronym / sponsor ID
- AK2016-2
- Conditions
- Glioblastoma Multiforme
- Keywords
- urokinase plasminogen activator receptor, positron emission tomography, glioblastoma multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uPAR PET/MRI | Experimental | Drug: One injection of 68Ga-NOTA-AE105, Device: PET/MRIOne injection of 68Ga-NOTA-AE105 followed by PET/MRI. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy
- Lactation/breast feeding
- Age above 85 years old
- Weight above 140 kg
- Known allergy towards 68Ga-NOTA-AE105
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One injection of 68Ga-NOTA-AE105One injection of 68Ga-NOTA-AE105 | Drug | uPAR PET/MRI |
| PET/MRIFollowing injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain | Device | uPAR PET/MRI |
Primary outcome
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)
uPAR PET/MRI prognostic factor for overall survival
Time frame: 36 months
Patients will be followed for 36 months after uPAR/PET MRI
1 secondary outcome
uPAR PET/MRI prognostic factor for progression free survival
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Derived from this study: PubMed 39472354Azam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorthe Skovgaard, Md, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing One injection of 68Ga-NOTA-AE105 and PET/MRI in people with Glioblastoma Multiforme, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorthe Skovgaard, MD, PhD (+4561274706, dskovgaard@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uPAR PET/MRI imaging of uPAR expression (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.