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

Rekrutierend

NCT-Nummer:
NCT05911230

Studienbeginn:
November 2022

Letztes Update:
22.06.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Glioblastoma, Brain Neoplasms, Recurrence

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Basel, Switzerland

Collaborator:
-

Studienleiter

Dominik Cordier, PD Dr. med.
Principal Investigator
University Hospital, Basel, Switzerland

Kontakt

Dominik Cordier, PD Dr. med.
Kontakt:
Phone: +41 61 26 56 42
E-Mail: dominik.cordier@usb.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Basel
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Dominik Cordier, PD Dr. med.
E-Mail: dominik.cordier@usb.ch

Cristina Granziera, PD Dr. med.
E-Mail: cristina.granziera@usb.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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))

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov