uPAR-PET/MR in glioma

uPAR-PET/MR in glioma - uPAR-PET/MR in glioma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002417-21-DK

Enrollment

Registered

2016-08-03

Start date

2016-09-22

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gliomas MedDRA version: 20.0 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10018338 Term: Glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: 68Ga-NOTA-AE015 Product Code: 68Ga-NOTA-AE105 Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: 68Ga-NOTA-AE105 CAS Number: NA Current

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Suspicion of glioma based on either CT or MRI The participants must be capable of understanding and giving full informed written consent Age above 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Pregnancy Lactation/breast feeding Age above 85 years old Weight above 140 kg Known allergy towards 68Ga-NOTA-AE105

Design outcomes

Primary

Measure	Time frame
Main Objective: In this study with PET uPAR we include patients suspected of gliomas (including the sub-diagnosis glioblastoma) in order to investigate the diagnostic performance of uPAR PET for non-invasive tumor delineation and determination of uPAR expression in glioma tissue. Furthermore, we examine the prognostic value of uPAR-PET for predicting overall survival. The scan will be performed as a uPAR-PET combined with MRI (for some patients CT brain) as a baseline scan prior to either stereotactic biopsy, surgery, radio- or chemotherapy. The uptake of the tracer 68Ga-NOTA-AE105 will be compared with uPAR expression determined directly in tumor biopsies (stereotactic/surgery) if available.;Secondary Objective: Not applicable;Primary end point(s): Correlation of uptake of 68Ga-NOTA-AE105 in tumor with uPAR expression measured directly in tumor biopsies Correlation of uptake of 68Ga-NOTA-AE105 in tumor and overall survival;Timepoint(s) of evaluation of this end point: Evaluation of the primary endpoints from uPAR PET scan performed within 1 hour post injection of 68Ga- NOTA-AE10 Overall survival: 36 months following uPAR-PET scan	—

Measure

Time frame

Main Objective: In this study with PET uPAR we include patients suspected of gliomas (including the sub-diagnosis glioblastoma) in order to investigate the diagnostic performance of uPAR PET for non-invasive tumor delineation and determination of uPAR expression in glioma tissue. Furthermore, we examine the prognostic value of uPAR-PET for predicting overall survival. The scan will be performed as a uPAR-PET combined with MRI (for some patients CT brain) as a baseline scan prior to either stereotactic biopsy, surgery, radio- or chemotherapy. The uptake of the tracer 68Ga-NOTA-AE105 will be compared with uPAR expression determined directly in tumor biopsies (stereotactic/surgery) if available.;Secondary Objective: Not applicable;Primary end point(s): Correlation of uptake of 68Ga-NOTA-AE105 in tumor with uPAR expression measured directly in tumor biopsies Correlation of uptake of 68Ga-NOTA-AE105 in tumor and overall survival;Timepoint(s) of evaluation of this end point: Evaluation of the primary endpoints from uPAR PET scan performed within 1 hour post injection of 68Ga- NOTA-AE10 Overall survival: 36 months following uPAR-PET scan

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactAleena Azam

Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET

aleena.azam@regionh.dk004535456208

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026