Glioblastoma (GBM)AiD-GLIONCT05911230
Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases
A study testing Advanced diffusion-weighted MRI (ADW-MRI) in people with Glioblastoma (GBM), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- Advanced diffusion-weighted MRI (ADW-MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Nov 2022to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Dominik Cordier, PD Dr. med., dominik.cordier@usb.ch
Cristina Granziera, PD Dr. med., cristina.granziera@usb.ch
About this study
Official title: Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases- AiD GLIO Pilot Trial
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.
- Conditions
- Glioblastoma (GBM)
- Being tested
- Advanced diffusion-weighted MRI (ADW-MRI)
- Keywords
- Advanced Diffusion Weighted Magnetic Resonance Imaging (ADW-MRI), Tumor Progress (TP), Pseudo- Progression (PsP)
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced diffusion-weighted MRI (ADW-MRI)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| ADW-MRI imaging | Other | 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. Receives: Diagnostic Test: Advanced diffusion-weighted MRI (ADW-MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start24 Nov 2022
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- one-arm, monocentric pilot trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominik Cordier, PD Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911230
- Sponsor's protocol ID
- 2022-00888; ko23Cordier
- Acronym
- AiD-GLIO
- Status last verified
- Jan 2025
- First submitted
- 7 Jun 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases- AiD GLIO Pilot Trial
- ClinicalTrials.gov ID
- NCT05911230
- Acronym / sponsor ID
- AiD-GLIO / 2022-00888; ko23Cordier
- Conditions
- Glioblastoma (GBM)
- Keywords
- Advanced Diffusion Weighted Magnetic Resonance Imaging (ADW-MRI), Tumor Progress (TP), Pseudo- Progression (PsP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 20 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one-arm, monocentric pilot trial
| Arm | Type | Receives |
|---|---|---|
| ADW-MRI imaging | Other | Diagnostic Test: Advanced diffusion-weighted MRI (ADW-MRI)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced 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. | Diagnostic test | ADW-MRI imaging |
Primary outcome
Correlation of ADW-MRI-findings to histopathological findings
Time frame: one time assessment at baseline
Correlations between standard histopathologic workup of the resected tissue and the results concerning tissue features from ADW-MRI are analyzed (descriptive analysis))
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dominik Cordier, PD Dr. med. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced diffusion-weighted MRI (ADW-MRI) in people with Glioblastoma (GBM), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominik Cordier, PD Dr. med. (+41 61 26 56 42, dominik.cordier@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of ADW-MRI-findings to histopathological findings (time frame: one time assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.