NCT05402241Completed
IRD at Admission Predicts Survival of GBM Patients - a Prospective Pilot Study
Isolated Restricted Diffusion at Admission Predicts Survival in Patients of Glioblastoma Multiforme (IRD GBM)- A Prospective Pilot Study
Source: ClinicalTrials.gov · Last updated 23 May 2024
Brief summary (registry, in English)
Glioblastomas (GBM) are the most common primary malignant brain tumor with a very high recurrence rate and an average survival of 14 months. Identifying an imaging biomarker to predict recurrence is critical. Using a special MRI technique called diffusion weighted imaging (DWI), a recent retrospective study described isolated restricted diffusion (IRD) foci. The presence of IRD was found in 40% of patients with GBM on index imaging and was associated with longer survival. IRD foci are not currently identified as having a tumor focus and are not included in treatment strategies and guidelines. These findings need to be confirmed in a prospective study. The investigators propose a prospective pilot study to establish the incidence of IRD on the index imaging of patients with GBM. The investigators will collect surgical samples from these foci to establish the histological and molecular signature to confirm GBM in these newly identified foci. The results from this pilot study will guide the planning of a larger well powered multicenter study that will help establish IRD as an imaging biomarker in the GBM management guidelines, which will help improve the outcomes in patients with GBM.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 52 (actual)
- First submitted
- 22 Oct 2021
- Start date
- 21 Oct 2021
- Primary completion date
- 15 Nov 2023
- Lead sponsor
- University of Manitoba
- Diseases
- Glioblastoma
- NCT number
- NCT05402241
What you commit to
- Study type: Observational
- Participants enrolled: 52
- From 21 Oct 2021 to the primary completion date, 15 Nov 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known contraindication to MRI contrast agent, e.g., allergy or anaphylactic reaction
- Known end-stage renal disease
Other
- Participants who are pregnant
Who the study is looking for
- At least 18 years old
- Patients with suspected GBM on initial MRI of brain
- MRI scans with isolated restricted diffusion foci noted
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Manitoba | Winnipeg | Canada | Unknown status |
| Health Sciences Centre | Winnipeg MB | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.