uPAR-PET/MRI in Glioblastoma Multiforme

NCT ID: NCT02945826

Last Updated: 2018-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Glioblastoma Multiforme

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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uPAR PET/MRI

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

Group Type EXPERIMENTAL

One injection of 68Ga-NOTA-AE105

Intervention Type DRUG

One injection of 68Ga-NOTA-AE105

PET/MRI

Intervention Type DEVICE

Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain

Interventions

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One injection of 68Ga-NOTA-AE105

One injection of 68Ga-NOTA-AE105

Intervention Type DRUG

PET/MRI

Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Dorthe Skovgaard

Principal investigator, MD, Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dorthe Skovgaard, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Dorthe Skovgaard, MD, PhD

Role: CONTACT

+4561274706

Kjaer Andreas, professor

Role: CONTACT

+4535454011

Facility Contacts

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Dorthe Skovgaard, MD, Phd

Role: primary

+4561274706

Andreas Kjaer, Professor

Role: backup

+4535454011

References

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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.

Reference Type DERIVED
PMID: 39472354 (View on PubMed)

Other Identifiers

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2016-002417-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AK2016-2

Identifier Type: -

Identifier Source: org_study_id

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