Glioblastoma Imaging for the Detection of Tumor Progression Using APTw-CEST MRI

NCT07121842 | Recruiting

• 1 other identifier: NL86895.078.24
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

In this study, the invesigators look at how a new MRI technique (called amide proton transfer weighted (APTw) chemical exchange saturation transfer (CEST)) can improve treatment for brain tumors through early detection of tumor progression after radiotherapy and/or chemotherapy treatment. An issue with the current treatment for patients with a brain tumor, is the inability to detect tumor progression early. An abnormality is seen on MRI scans taken shortly after treatment with radiotherapy in about 30% of patients. This abnormality may be a sign that radiotherapy treatment has worked well and will disappear on its own after a while. However, an abnormality can also be a sign of active tumor tissue. Then it shows that the treatment has not worked well enough. When there is active tumor tissue, this is called 'tumor progression'. When there is an abnormality that disappears on its own after a while, there is no active tumor tissue. This is called 'pseudoprogression'. Currently, there are two options to determine whether tumor progression or pseudoprogression has taken place: Do another brain surgery to see if the abnormality contains active tumor tissue or wait and have regular MRI scans until it is clear whether the abnormality goes away on its own. Amide proton transfer weighted chemical exchange saturation transfer (APTw-CEST) imaging is a new MRI technique in which investigators can produce images that show the accumulation of protein. APTw-CEST has previously been shown to be able to distinguish tumor progression from pseudoprogression earlier than current standard MRI scans. However, these previous studies have drawbacks: they were either done with a small group of patients in 1 hospital, or with a 7 Tesla MRI scanner, a rare type of scanner not standard in hospitals, or done in animal models. In this research project the investigators now want to prepare APTw-CEST for standard patient care for patients with glioblastoma in the Netherlands so that in the future APTw-CEST can be included as a standard scan during treatment. The investigators are doing this by introducing APTw-CEST MRI on the clinical MRI scanners of four different hospitals. Ultimately, the investigators want to use this to create national guidelines for measuring and viewing APTw-CEST MRI images for early detection of tumor progression.

Conditions

Glioblastoma

Keywords

Glioblastoma; MRI; CEST; Pseudoprogression; multi-center; APTw-CEST

Outcome Measures

Primary Outcomes (1)

• Determining the Threshold

  Determine the optimal threshold on APTw-CEST images in a multi-center (4 aca-demic institutes) multi-vendor (Philips, Siemens and GE) clinical trial, to distinguish tumor progression from treatment-related effects.

  Until 1 year after the first MRI scan with the additional APTw-CEST added

Secondary Outcomes (1)

• Correlations with other MRI and PET scans.

  Up until 1 year from the date of the first MRI scan with added APTw-CEST

Study Arms (1)

Extended MRI

OTHER

The MRI protocol for every clinical MRI scan taken in follow-up is extended with 15 minutes.

Diagnostic Test: Extended MRI

Interventions

Extended MRI DIAGNOSTIC_TEST

The MRI protocol for every clinical follow-up MRI scan is extended with 15 minutes to add the APTw-CEST scan.

Extended MRI

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of glioblastoma based on histopathological or molecular analysis of biopsy after surgery, or suspected of glioblastoma based on medical imaging.
• Scheduled to undergo radiotherapy or combined chemo-and radiotherapy
• years and older
• Able to give informed consent.
• Patient will undergo clinically indicated MRIs

You may not qualify if:

• Not able to give informed consent
• Contraindication for MRI
• Brain pathology affecting CEST contrast, such as recent stroke or earlier cranial radiotherapy, as determined by the principal investigators (PIs)

Sponsors & Collaborators

• Erasmus Medical Center: lead
• UMC Utrecht: collaborator
• LeidenUMC: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (4)

Amsterdam UMC

Amsterdam, Netherlands

NOT YET RECRUITING

Leiden UMC

Leiden, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

Related Links

• Related Info
• Related Info

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

Central Study Contacts

Laura Kemper, MSc

CONTACT

+310630720232; l.kemper@erasmusmc.nl

Esther Warnert, PhD, MSc

CONTACT

e.warnert@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: Assistant Professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 14, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

NL (4)