Testing a new radiotracer for visualization of the high grade brain tumor glioblastoma multiforme

Phase 1

• Conditions: Patients with suspected/detected GBM on T1w-Gd-MRI; MedDRA version: 20.0Level: LLTClassification code 10006153Term: Brain tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10053764Term: Brain tumor operationSystem Organ Class: 100000004865; MedDRA version: 20.0Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2018-000046-19-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-26
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

-Suspected GBM on MRI scan
-Scheduled for tumor resection at Radboudumc
-Age =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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-Age < 18 years
-Pregnancy or the wish to become pregnant within 6 months
-Creatinine clearance below 40ml/min
-Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified