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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-24

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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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

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Glioblastoma (GBM)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

one-arm, monocentric pilot trial

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Advanced diffusion-weighted MRI (ADW-MRI)

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No