uPAR PET/MRI in glioma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-01-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2024-519723-20-01

EudraCT number

2016-002417-21

ClinicalTrials.gov

NCT02945826

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

1) uPAR-PET/MR/uPAR-PET/CT with the tracer 68Ga-NOTA-AE105 can be used to:

a. Visualize gliomas, where the uptake of 68Ga-NOTA-AE105 correlates directly with uPAR expression, as determined by immunohistochemical analysis of stereotactically obtained tumor biopsies or biopsies taken during surgery.
b. Differentiate high-grade gliomas from low-grade gliomas based on differentiated uptake of the tracer due to varying levels of uPAR expression.
c. Preoperatively differentiate between glioma progression/recurrence and post-therapeutic effects based on differentiated uptake of the tracer due to varying levels of uPAR expression.

2) uPAR-PET/MR/uPAR-PET/CT with high uptake of the tracer 68Ga-NOTA-AE105 in the brain tumor is associated with shorter survival.

Conditions and MedDRA coding

Glioma

Regulatory references

Plan to share IPD

Yes

IPD plan description

IPD will be shared in compliance with the 10-year retention period outlined in the protocol. Purpose: o Regulatory reviews, including compliance with Clinical Trials Regulation (CTR). o Post-trial assessments, including safety and efficacy validations. o Scientific analysis for secondary objectives and exploratory outcomes. Data Categories: o De-identified participant data: Imaging data from uPAR-PET/MR scans (e.g., SUV values), safety data, tumor pathology results, follow-up data, including survival. Availability: o Available starting 6 months after trial completion/publication and remain accessible for 10 years post-study completion, as stated in the protocol. Recipients: Authorized Recipients including, regulatory bodies (e.g., EMA, FDA), Good Clinical Practice (GCP) monitors and auditors, institutional review boards, ethics committees, and foreign health authorities for regulatory registration purposes. How: o Via encrypted, secure electronic platforms in accordance with GDPR

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Patients aged above 18 years old where imaging (brain MRI or CT) indicate suspicion of glioma and who are referred/planned for stereotactic biopsy, surgery, or oncological treatment. Only patients who are able to understand the patient information and provide informed consent will be included.

Exclusion criteria 1

1. Pregnancy. Lactation. Claustrophobia. Age > 85 years. Severe obesity (> 140 kg). Known allergy to the tracer 68Ga-NOTA-AE105

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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)

Secondary endpoints 1

1. The prognostic significance of uPAR expression, as assessed by uPAR-PET/MRI, will be evaluated for its correlation with overall and progression free survival. Patients will be followed for a total of 36 months post uPAR-PET/MRI

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Blegdamsvej 9

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Aleena Azam

Public contact point

Organisation

Rigshospitalet

Contact name

Aleena Azam

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications