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Glioblastoma Imaging Using a Strong Iron-like Bloodpool Contrast Medium?

NCT05656300 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2022-12-19

No results posted yet for this study

Summary

Rationale: Visualization of tumor spread is of crucial importance when treating patients suffering from glioblastoma (GBM) as the success of tumor resection depends strongly on the extent of tumor infiltration. Current MRI protocols, however, cannot visualize the extent the tumor infiltration. The use of non-toxic, non-dangerous ultrasmall superparamagnetic biodegradable iron oxide (USPIO) particles as a very strong blood pool contrast agent could help visualizing this invisible infiltration Objective: To what extent, do GBMs infiltrate healthy brain tissue and can we use ultrasmall superparamagnetic iron oxide particles to visualize co-opting infiltrating tumor cells in an attempt to predict regions of tumor recurrence? Study design: This study concerns a single arm prospective observational study. Study population: Patients diagnosed with suspected glioblastoma. Intervention (if applicable): USPIO neuroimaging Main study parameters/endpoints: The main parameter of this study concerns the feasibility of using of USPIO particles in healthy controls (n=6) and glioblastoma patients (n=15).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During this study patients will be intravenously injected with low doses of USPIOs. Risks involved with this procedure include: bruising of the skin after venapunction and allergic reaction to USPIO particles.

The application of USPIO neuroimaging can improve diagnosis of patients with suspected glioblastoma, provide more information on the pathophysiology of growth of glioblastoma lesiosn, the role of neuro-inflammation in these lesions and maybe predict regions of tumor recurrence after treatment.

Conditions

Interventions

DIAGNOSTIC_TEST

MRI scan using USPIO particles

Diagnostic imaging

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-04-01
Completion
2025-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05656300 on ClinicalTrials.gov