Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT05908669
Eligibility Criteria:
Inclusion Criteria:
* Patients with newly diagnosed GBM IDHwt
* Scheduled for long-course radiotherapy
* At least 18 years of age
* WHO performance status 0-1
* Women who are not postmenopausal or surgically sterile must have a negative serum or urine pregnancy test performed at time of inclusion in the study. Safe and highly effective contraception must be used throughout the study meaning either hormonal anti-conception or an anti-fertility intrauterine device.
* Danish speaking
* Able and willing to comply after informed consent
Exclusion Criteria:
* Subjects who are receiving any other investigational agents.
* Previous or current treatment by radiation or chemotherapy.
* History of alcohol abuse or illicit drug use.
* Contraindications to MRI Pacemaker, neurostimulator or cochlea implant Metal foreign bodies such as fragments and irremovable piercings Unsafe medical implants Intracranial clips or coils Claustrophobia Largest circumference including arms \> 160 cm
* Contraindications to gadolinium contrast eGFR ≤ 30 mL/min/1.73m2 Previous adverse reactions to gadolinium
* Not able or willing to receive radiotherapy
* Predicted remaining survival \<3 months
* Insulin-treated diabetes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05908669
Study Brief:
Protocol Section:
NCT05908669