Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Incidence of isolated restricted diffusion (IRD) in GBM patients
- timeFrame
- Upon completion of the study, which will be approximately 2 years
- description
- proportion of GBM participants with IRD
- measure
- Incidence of IRD foci proceeding to contrast enhancement on 3 month follow up
- timeFrame
- through completion of the study approximately 2 years
- description
- proportion of participants that have contrast enhancement on 3 month follow-up
- measure
- Incidence of IRD foci proceeding to contrast enhancement on 6 month follow up
- timeFrame
- through completion of the study approximately 2 years
- description
- proportion of participants that have contrast enhancement on 6 month on follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years old * Patients with suspected GBM on initial MRI of brain * MRI scans with isolated restricted diffusion foci noted Exclusion Criteria: * Participants who are pregnant * Known contraindication to MRI contrast agent, e.g., allergy or anaphylactic reaction * Known end-stage renal disease
References
Publications (0)
Data not yet available