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

Glioblastoma (GBM) Clinical Trial

— AiD-GLIO  

Official title:

Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases- AiD GLIO Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911230
• Other study ID #: 2022-00888; ko23Cordier
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2022
• Est. completion date: April 2024

Study information

• Verified date: June 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Dominik Cordier, PD Dr. med.
• Phone: +41 61 26 56 42
• Email: dominik.cordier[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioblastoma
• Glioblastoma (GBM)
• Recurrence

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))	one time assessment at baseline