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Clinical Trials in the Netherlands / NCT05970757
Active, not recruiting Not applicable

Physiological MRI for Precision Radiotherapy IDH-wildtype Glioblastoma

NCT05970757 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Erasmus Medical Center
Phase
Not applicable
Started
2022-07-14
Last updated
2025-08-11

Condition(s) studied

Glioblastoma

Investigational drug(s) / intervention(s)

Extended MRI

Extended MRI: Extension of the brain tumor MRI-protocol

Study summary

After surgery, a key step in treatment of patients diagnosed with glioblastoma (high grade brain tumour) is radiotherapy. The ideal clinical target volume (CTV) for radiotherapy treatment planning includes all tumour cells remaining after surgery. Currently, the GTV is delineated on conventional imaging techniques that are only visualizing macroscale structural changes due to the presence of a large number of tumour cells. After delineating these visible macroscale changes, the GTV is expanded in all directions with 1.5cm into visibly healthy tissue to account for microscale tumour invasion. This standard CTV therefore also contains healthy tissue that should not be receiving radiation, causing side effects of treatment, hereby reducing quality of life for patients.

Generating a physiological CTV, in which microscale invasion of tumour cells is taken into account specifically whilst sparing healthy tissue that is not in need of radiation, is essential for reducing side effects of radiotherapy. To do so, visualisation is necessary of physiological processes of tumour cells, which are present before macroscale structural changes occur. State-of-the-art MRI techniques are now in use at the Erasmus MC that can assess these physiological processes, including oxygenation status and cell proliferation.

We aim to generate proof-of-concept of using a physiological CTV for radiotherapy treatment planning for patients with brain tumours. By extending the clinical standard MRI session used for radiotherapy planning in 10 patients diagnosed with glioblastoma with advanced MRI techniques that assess oxygenation status and cell proliferation, we will generate the physiological CTV including this information and illustrate that it is more precise in capturing microscale tumour invasion. This proof-of-principle work will be used to obtain external funding to perform the much needed, and the first of its kind globally, clinical trial to show the benefit of a physiological CTV for radiotherapy treatment planning in glioblastoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Informed consent; * Adults (18 years or older); * diagnosed with IDH-wildtype glioblastoma, as confirmed by pathology including molecular analysis post resection/biopsy; * referred to outpatient clinic of the Department of Radiotherapy to undergo standard treatment with high-dose RT. * Patients eligible for 30x2Gy or 15x2.67Gy Exclusion Criteria: * Contraindication for MRI * Contraindication for use of gadolinium-based contrast agent (i.e. subject having renal deficiency) * Unable to give informed consent

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Erasmus Medical Center Rotterdam South Holland

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Other trials for the same condition

The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302) Recruiting
Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study. Starting soon
Hitting the Mark: Introducing State-of-the-art MRI for Precision Radiotherapy of Glioblastoma Recruiting
Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma Recruiting
The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05970757 on ClinicalTrials.gov ↗ ← All trials in the Netherlands