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Multimodal image-guided resection of IDH-wildtype glioblastoma and grade IV IDH-mutant astrocytoma

Multimodal image-guided resection of IDH-wildtype glioblastoma and grade IV IDH-mutant astrocytoma - Next FRONTIER

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56595
Enrollment
30
Registered
2023-12-22
Start date
2024-05-21
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

brain tumor glioblastoma

Interventions

Supramarginal resection will be guided by ADC/FET. To make sure that the standard treatment is always guaranteed, T1c MRI abnormalities will be included in the surgical target.

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years - New clinical and radiological suspected diagnosis of IDH-wildtype glioblastoma or grade IV IDH-mutant astrocytoma - Indication for a surgical resection and adjuvant treatment according to the neuro oncology multidisciplinary meeting - Eligible for a supramarginal resection according to two neurosurgeons in consensus - Karnofsky Performance Score (KPS) >= 70

Exclusion criteria

Exclusion criteria: - Previous brain surgery or cranial radiotherapy - Significant other brain pathology, in the opinion of the PI or designee, such as multiple sclerosis, neurodegenerative disease, stroke - Tumor located infratentorially or in the spinal cord - Lack of adequate social or family support needed for adherence to the further postoperative therapeutic regimen - Pregnancy

Design outcomes

Primary

MeasureTime frame
The main study endpoint is the optimization of ADC/FET-guided resection. Volumetric and percentual extent of resection, as measured with MRI and PET imaging, combined with surgery-induced morbidity will be used as outcome parameters.

Secondary

MeasureTime frame
The secondary study parameters will be the histopathology-based diagnostic accuracy of APT-CEST MRI in comparison with FET PET, cognitive performance over time and progression free survival.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)