search
Back to results

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

Primary Purpose

Glioblastoma (GBM)

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Advanced diffusion-weighted MRI (ADW-MRI)
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma (GBM) focused on measuring Advanced Diffusion Weighted Magnetic Resonance Imaging (ADW-MRI), Tumor Progress (TP), Pseudo- Progression (PsP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital BaselRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ADW-MRI imaging

Arm Description

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.

Outcomes

Primary Outcome Measures

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))

Secondary Outcome Measures

Full Information

First Posted
June 7, 2023
Last Updated
June 21, 2023
Sponsor
University Hospital, Basel, Switzerland
search

1. Study Identification

Unique Protocol Identification Number
NCT05911230
Brief Title
Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases
Acronym
AiD-GLIO
Official Title
Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases- AiD GLIO Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma (GBM)
Keywords
Advanced Diffusion Weighted Magnetic Resonance Imaging (ADW-MRI), Tumor Progress (TP), Pseudo- Progression (PsP)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
one-arm, monocentric pilot trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADW-MRI imaging
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Advanced diffusion-weighted MRI (ADW-MRI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation of ADW-MRI-findings to histopathological findings
Description
Correlations between standard histopathologic workup of the resected tissue and the results concerning tissue features from ADW-MRI are analyzed (descriptive analysis))
Time Frame
one time assessment at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominik Cordier, PD Dr. med.
Phone
+41 61 26 56 42
Email
dominik.cordier@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik Cordier, PD Dr. med.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Cordier, PD Dr. med.
Email
dominik.cordier@usb.ch
First Name & Middle Initial & Last Name & Degree
Cristina Granziera, PD Dr. med.
Email
cristina.granziera@usb.ch
First Name & Middle Initial & Last Name & Degree
Dominik Cordier, PD Dr. med.
First Name & Middle Initial & Last Name & Degree
Cristina Granziera, PD Dr. med.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs