IRD at Admission Predicts Survival of GBM Patients - a Prospective Pilot Study

NCT05402241 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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

Glioblastoma Multiforme

Keywords

Glioblastoma, Multiforme; Isolated Restricted Diffusion foci

Outcome Measures

Primary Outcomes (6)

• Incidence of isolated restricted diffusion (IRD) in GBM patients

  proportion of GBM participants with IRD

  Upon completion of the study, which will be approximately 2 years

• Incidence of IRD foci proceeding to contrast enhancement on 3 month follow up

  proportion of participants that have contrast enhancement on 3 month follow-up

  through completion of the study approximately 2 years

• Incidence of IRD foci proceeding to contrast enhancement on 6 month follow up

  proportion of participants that have contrast enhancement on 6 month on follow-up

  through completion of the study approximately 2 years

• Incidence of IRD foci that are from the GMB foci

  proportion of IRD foci that originate from the GBM foci

  through completion of the study, approximately 2 years

• relationship of molecular alteration with GBM foci and the IRD

  descriptive analysis

  Upon completion of the study approximately 2 years

• Survival patterns of GBM participants with IRD

  mortality

  Upon completion of the study approximately 2 years

Eligibility Criteria

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

Study Population

newly diagnosed patients with GBM

You may qualify if:

• At least 18 years old
• Patients with suspected GBM on initial MRI of brain
• MRI scans with isolated restricted diffusion foci noted

You may not qualify if:

• Participants who are pregnant
• Known contraindication to MRI contrast agent, e.g., allergy or anaphylactic reaction
• Known end-stage renal disease

Sponsors & Collaborators

• University of Manitoba: lead
• CancerCare Manitoba: collaborator

Study Sites (2)

University of Manitoba

Winnipeg, Manitoba, R3E 3P5, Canada

Location

Health Sciences Centre

Winnipeg MB, Manitoba, R3A 1R9, Canada

Location

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

• Jai Shankar, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: June 2, 2022
• Study Start: October 21, 2021
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: May 23, 2024

Record last verified: 2024-01

Locations

CA (2)