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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05402241
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Manitoba
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jai Shankar, MD
Principal Investigator Affiliation	University of Manitoba
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Completed
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme

Additional Details

Glioblastomas (GBM) are the most common type of primary malignant brain tumor with a very high rate of recurrence. The average survival of patients with GBM is 14 months, and the 5-year survival rate is approximately 4 to 5%. Identifying an imaging biomarker to predict recurrence is critical. Using a special MRI technique called diffusion weighted imaging (DWI), the investigators recently described a focus of isolated restricted diffusion (IRD) in a retrospective study. Presence of IRD was found in 40% of patients with GBM on index imaging and was associated with longer survival. The foci of IRD are not currently identified as having a tumor focus and are not included in treatment strategies and guidelines. The results from this pilot study will help plan for a larger well powered multicenter study that will help establish IRD as an imaging biomarker in the GBM management guidelines. The investigators hypothesize that IRD foci when present, are foci of GBM and when untreated, will be the site of recurrence. This pilot study will use a prospective cohort study design, to establish the incidence of IRD on the index imaging of participants with GBM. Surgical samples will be collected from these foci to establish the histological and molecular signature to confirm GBM in these newly identified foci. The study population will include patients that present with newly diagnosed with GBM. All newly diagnosed GBM participants will be screened for the study using the study inclusion and exclusion criteria. After the standard of care MRI/DWI is done and reviewed, eligible participants will be approached by the research team, for discussion of the study and potential consent for participation. All participants will undergo further treatment and management as per institutional standard including the clinical and imaging follow up. Each MRI will be screened by experienced neuro-radiologists to identify the presence of isolated restricted diffusion foci. In those participants with isolated restricted diffusion foci on MRI, the neurosurgeon (on for the day) will assess the feasibility and safety of targeted biopsy from this focus. The targeted biopsy will only be considered when it is deemed safe and feasible based on the location and surgical approach, which will be determined by the neurosurgeon. This will reduce any undue risk for research purposes. The biopsy samples will undergo standard of care laboratory histopathological and molecular testing to establish the pathological and molecular signatures of these tumors. The neuropathologic examination will be performed by neuropathologists. Informed consent will be obtained from the patients to participate in the study. The aim of this study is to establish a new imaging biomarker and to determine its association with known molecular alterations in GBM. The investigators will also explore the incidence of isolated restricted diffusion in GBM participants, the number of IRD foci that proceed to contrast enhancement on follow up, the true number of IRD foci, and the survival pattern of the study participants with isolated restricted diffusion.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Health Sciences Centre, Winnipeg MB, Manitoba, Canada

Status

Address

Health Sciences Centre

Winnipeg MB, Manitoba, R3A 1R9

University of Manitoba, Winnipeg, Manitoba, Canada