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RecruitingNCT05911230AiD-GLIOUpdated Jan 29, 2025

Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases

An interventional study of Advanced diffusion-weighted MRI (ADW-MRI) in Glioblastoma (GBM), sponsored by University Hospital, Basel, Switzerland. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Nov 2022, registered Jun 2023).
  • Started Nov 2022; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This pilot study investigates whether advanced diffusion-weighted MRI (ADW-MRI) can differentiate between true tumor progression (TP) and a pseudoprogression (PsP) in patients with glioblastoma (GBM) or brain metastases.

Read the detailed description

Advanced diffusion-weighted MRI (ADW-MRI) offer the opportunity of higher sensitivity towards subtle tissue changes associated with increased specificity relating to damage of different tissue components of the central nervous system (CNS). Within the framework of this study, conventional follow up MRI will be complemented by ADW-MRI in case of suspected tumor recurrence and possible surgical resection of the suspicious tissue. In the case of surgical resection, the histopathological findings will be correlated to the findings of the ADW-MRI. In the depicted pilot phase, the feasibility of the described protocol will be examined and the data concerning correlations between standard histopathologic and genetic workup of the resected tissue and the results concerning tissue features from ADW-MRI will be analyzed.

02

Conditions studied

  • Glioblastoma (GBM)

Keywords

  • Advanced Diffusion Weighted Magnetic Resonance Imaging (ADW-MRI)
  • Tumor Progress (TP)
  • Pseudo- Progression (PsP)
03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's planned enrollment of 10 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with histopathologically proven glioblastoma or brain metastasis and suspected tumor progress on standard MRI after first line therapy and who are candidates for elective surgical resection.
  • Able to give informed consent

Exclusion criteria

Exclusion Criteria:

  • Contraindications to MRI (e.g. claustrophobia, pacemaker or other implants without MRI-approval, pregnancy)
  • Patients in a life-threatening condition
  • Patients in need of emergent surgery
  • Histopathological analyses of insufficient quality
  • Unable to give informed consent
  • Age \<18 Years
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Other
    ADW-MRI imaging

    Patients with a histopathologically proven glioblastoma or brain metastasis who have suspected tumor progression on standard MRI after standard first line therapy and who are candidates for surgical resection and undergoing the ADW-MRI preoperatively.

    Diagnostic Test: Advanced diffusion-weighted MRI (ADW-MRI)

Interventions

  • Diagnostic testAdvanced diffusion-weighted MRI (ADW-MRI)

    An advanced diffusion weighted MRI-sequence will be performed in addition to the routine MRI-diagnostics. This will require the patient to be scanned for additional 30 minutes in a separate MRI-scanner. This technique offers the opportunity of higher sensitivity towards subtle tissue changes associated with increased specificity relating to damage of different tissue components of the CNS. In the case of surgical resection, the histopathological findings will be correlated to the findings of the ADW-MRI.

06

What researchers measure

Primary outcomes

  1. Correlation of ADW-MRI-findings to histopathological findings

    Correlations between standard histopathologic workup of the resected tissue and the results concerning tissue features from ADW-MRI are analyzed (descriptive analysis))

    Time frame: one time assessment at baseline

07

Study locations

1 of 1 sites recruiting
  • University Hospital Basel
    Basel, 4031, Switzerland
    • Dominik Cordier, PD Dr. med. · Contact · dominik.cordier@usb.ch
    • Cristina Granziera, PD Dr. med. · Contact · cristina.granziera@usb.ch
    • Dominik Cordier, PD Dr. med. · Principal investigator
    • Cristina Granziera, PD Dr. med. · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05911230
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Jun 20, 2023
Start date
Nov 24, 2022
Primary completion
Nov 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Jan 29, 2025

Study contacts

Dominik Cordier, PD Dr. med.
Contact
dominik.cordier@usb.ch
+41 61 26 56 42
Dominik Cordier, PD Dr. med.
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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