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Trial Title:
Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases
NCT ID:
NCT05911230
Condition:
Glioblastoma (GBM)
Conditions: Official terms:
Glioblastoma
Brain Neoplasms
Recurrence
Conditions: Keywords:
Advanced Diffusion Weighted Magnetic Resonance Imaging (ADW-MRI)
Tumor Progress (TP)
Pseudo- Progression (PsP)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
one-arm, monocentric pilot trial
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Advanced diffusion-weighted MRI (ADW-MRI)
Description:
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.
Arm group label:
ADW-MRI imaging
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.
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.
Criteria for eligibility:
Criteria:
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:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Basel
Address:
City:
Basel
Zip:
4031
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Dominik Cordier, PD Dr. med.
Email:
dominik.cordier@usb.ch
Contact backup:
Last name:
Cristina Granziera, PD Dr. med.
Email:
cristina.granziera@usb.ch
Investigator:
Last name:
Dominik Cordier, PD Dr. med.
Email:
Principal Investigator
Investigator:
Last name:
Cristina Granziera, PD Dr. med.
Email:
Sub-Investigator
Start date:
November 24, 2022
Completion date:
April 2024
Lead sponsor:
Agency:
University Hospital, Basel, Switzerland
Agency class:
Other
Source:
University Hospital, Basel, Switzerland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05911230
