Clinical trial • Not applicable • Oncology|Neurology|Other

[68GA]GA-NOTA-AE105 for Glioma

Not applicable trial of [68GA]GA-NOTA-AE105 for Glioma. 61 participants.

Overview

Trial Therapeutic Area
Oncology|Neurology|Other
Trial Disease
Glioma
Trial Stage
Not applicable
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
28-01-2025
First CTIS Authorization Date
29-01-2025

Trial design

Not applicable trial across 1 site in Denmark.

Target Sample Size
61
Trial Duration For Participant
1095

Eligibility

Recruits 61 No vulnerable populations selected. Only adults (>18 years) able to understand the patient information and provide informed consent will be included; consent must be provided by the participant. No assent procedures described..

Pregnancy Exclusion
Pregnancy.
Vulnerable Population
No vulnerable populations selected. Only adults (>18 years) able to understand the patient information and provide informed consent will be included; consent must be provided by the participant. No assent procedures described.

Inclusion criteria

  • {"criterion_text":"- 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

  • {"criterion_text":"- Pregnancy.\n- Lactation.\n- Claustrophobia.\n- Age > 85 years.\n- Severe obesity (> 140 kg).\n- Known allergy to the tracer 68Ga-NOTA-AE105"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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)","definition_or_measurement_approach":"SUVs measured on uPAR-PET/MRI performed within 1 hour following injection of 68Ga-NOTA-AE105, compared with semiquantitative immunohistochemistry of uPAR from tumor biopsies."}

Secondary endpoints

  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Correlation of uPAR-PET/MRI measured uptake with overall survival and progression-free survival; participants followed for 36 months after uPAR-PET/MRI."}

Recruitment

Planned Sample Size
61
Recruitment Window Months
98
Consent Approach
Participants must be able to understand the patient information and provide informed consent. A subject information and informed consent form document is available. No assent or proxy consent procedures are described; consent provided by the participant.

Geography

Total Number Of Sites
1
Total Number Of Participants
61

Denmark

Earliest CTIS Part Ii Submission Date
26-01-2025
Latest Decision Or Authorization Date
29-01-2025
Processing Time Days
3
Number Of Sites
1
Number Of Participants
61

Sites

Site Name
Rigshospitalet
Department Name
Department of Neurosurgery
Principal Investigator Name
Aleena Azam
Principal Investigator Email
aleena_azam@outlook.dk
Contact Person Name
Aleena Azam
Contact Person Email
aleena_azam@outlook.dk
Number Of Participants
61

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Health care"}

Investigational products

Investigational Product Name
[68Ga]NOTA-AE105
Active Substance
[68GA]GA-NOTA-AE105
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Authorisation Status
Authorised (prodAuthStatus: 1)

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