Physiological MRI for Precision Radiotherapy IDH-wildtype Glioblastoma

NCT05970757 | Active Not Recruiting

• 1 other identifier: NL80747.078.22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma

Keywords

Glioblastoma; Precision radiotherapy; Advanced MRI

Outcome Measures

Primary Outcomes (1)

• Volume and location analysis of physiological and standard CTV

  Volume and location analysis (Dice correlation coeffcient) will be done to compare the physiological CTVs to standard CTVs generated pre-radiotherapy, where it is hypothesized that the physiological CTVs will be overall smaller in volume and better match microinvasion of the tumour than the standard CTV.

  Time frame is directly after the extended MRI-acquisition

Secondary Outcomes (1)

• Pattern-of-failure analysis of the physiological and standard CTV

  1 year

Study Arms (1)

Extended MRI group

OTHER

The MRI-scan time is extended with 15-20 minutes.

Diagnostic Test: Extended MRI

Interventions

Extended MRI DIAGNOSTIC_TEST

Extension of the brain tumor MRI-protocol

Extended MRI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

Related Publications (1)

• Tang PLY, Romero AM, Nout RA, van Rij C, Slagter C, Swaak-Kragten AT, Smits M, Warnert EAH. Amide proton transfer-weighted CEST MRI for radiotherapy target delineation of glioblastoma: a prospective pilot study. Eur Radiol Exp. 2024 Oct 30;8(1):123. doi: 10.1186/s41747-024-00523-4.

  PMID: 39477835 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Patrick Tang, MSc

  Erasmus Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor - Radiology & Nuclear medicine

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: July 14, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

NL (1)