Hitting the Mark: Introducing State-of-the-art MRI for Precision Radiotherapy of Glioblastoma

NCT06183983 | Recruiting DMC

• 1 other identifier: NL84994.078.23
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective cohort study is to assess the potential of advanced MRI for improved radiotherapy target delineation in patients diagnosed with glioblastoma. The main questions it aims to answer are:

• How does the coverage of the recurrence volume by a radiotherapy plan based on advanced MRI compare to the coverage by the clinical radiotherapy plan?
• How does the distribution of the dose to organs at risk by a radiotherapy plan based on advanced MRI compare to the distribution by the clinical radiotherapy plan? Participants will undergo an extended MRI-protocol prior to radiotherapy. This extended MRI-protocol includes the clinical brain tumor imaging protocol plus additional advanced MRI-sequences. Radiation treatment and patient follow-up will occur according to the clinical standard.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Pattern-of-failure analysis

  The primary outcome measure is a comparison of the pattern-of-failure by the radiotherapy plan based on CTVbio and the clinical radiotherapy plan (1.5-cm CTV). For both the clinical radiotherapy plan and the aMRI radiotherapy plan of each patient, the recurrence volumes will be classified as in-field, marginal, or distant recurrence if more than 80%, 20-80%, or less than 20% of the recurrence volume falls within the 95% isodose line, respectively.

  The time frame is until tumor recurrence occurs (follow-up for this study will last 2 years maximum for a participant).

Secondary Outcomes (3)

• Distribution of dose to organs at risk.

  Through study completion (on average 1 year after the extended MRI-scan).

• Recurrence coverage by different combinations of CTVbio

  The time frame is until tumor recurrence occurs (follow-up for this study will last 2 years maximum for a participant).

• Signal intensity on aMRI at the site of tumor recurrence

  The time frame is until tumor recurrence occurs (follow-up for this study will last 2 years maximum for a participant).

Study Arms (1)

Extended MRI group

OTHER

In this group, patients with a glioblastoma undergo an extended MRI-scan prior to radiotherapy.

Diagnostic Test: Extended or additional MRI-scan (with contrast) prior to radiotherapy

Interventions

Extended or additional MRI-scan (with contrast) prior to radiotherapy DIAGNOSTIC_TEST

The MRI-protocol before radiotherapy is extended with 20 minutes. Patients who would not have received an MRI-scan prior to radiotherapy, will get an extra MRI-scan when participating.

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:

• Written informed consent;
• Adult (18 years or older);
• Diagnosed with IDH-wildtype glioblastoma, as confirmed by pathology including molecular analysis post resection/biopsy;
• Referred to the outpatient clinic of the Dept. of Radiotherapy to undergo standard treatment with radiotherapy (30x2 Gy or 15x2.67Gy or 10x3.4Gy).

You may not qualify if:

• Contraindication for (3 Tesla) MRI;
• Contraindication for use of gadolinium-based contrast agent (e.g. subject having renal deficiency or known allergy);
• Referred for treatment of recurrent glioblastoma;
• Previous radiotherapy to the brain;
• Unable to give informed consent

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

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

• Alejandra Méndez Romero, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Tang, MSc

CONTACT

+31634271995; p.l.y.tang@erasmusmc.nl

René Vernhout, MSc

CONTACT

r.vernhout@erasmusmc.nl

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: Radiation oncologist and Associate professor - Department of Radiotherapy

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 28, 2023
• Study Start: January 3, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

NL (1)