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

NCT05911230 | Recruiting

• 1 other identifier: 2022-00888; ko23Cordier
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma (GBM)

Keywords

Advanced Diffusion Weighted Magnetic Resonance Imaging (ADW-MRI); Tumor Progress (TP); Pseudo- Progression (PsP)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Diagnostic Test: Advanced diffusion-weighted MRI (ADW-MRI)

Interventions

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.

ADW-MRI imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Dominik Cordier, PD Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Cordier, PD Dr. med.

CONTACT

+41 61 26 56 42; dominik.cordier@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one-arm, monocentric pilot trial

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 20, 2023
• Study Start: November 24, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

CH (1)