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NCT05970757Active, not recruiting

Physiological MRI for Precision Radiotherapy IDH-wildtype Glioblastoma

Source: ClinicalTrials.gov · Last updated 11 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
10 (estimated)
First submitted
24 Jul 2023
Start date
14 Jul 2022
Primary completion date
15 Dec 2023
Lead sponsor
Erasmus Medical Center
Diseases
Glioblastoma
NCT number
NCT05970757

What you commit to

  • Study type: Interventional
  • Planned participants: 10
  • From 14 Jul 2022 to the primary completion date, 15 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Contraindication for MRI
  • Contraindication for use of gadolinium-based contrast agent (i.e. subject having renal deficiency)
  • Unable to give informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Erasmus Medical Center
Coordinator of this site? Confirm its status
RotterdamNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.