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

NCT05656300 | Unknown DMC

• 1 other identifier: 83297
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Feasibility study of USPIO neuro-imaging in healthy participants (n=6)

  To investigate the dosage of USPIO administration for adequate neuro-imaging (e.g. signal to noise ratio optimization), 6 healthy participants will be included. Obtained images will be reviewed by a panel of radiologists to asses quality and diagnostic performance.

  18 months

Secondary Outcomes (2)

• Perform MR imaging of glioblastoma by use of a new Off Road multi-sequence protocol (i.e., T1w, T2w, FLAIR, DWI/DTI, SWI, T1w- and T2*w post-USPIO images) in 15 GBM patients.

  18 months

• Analyze the obtained images and characterize brain tissue using both a quantitative and qualitative methodology to delineate regions of tumor infiltration.

  18 months

Interventions

MRI scan using USPIO particles DIAGNOSTIC_TEST

Diagnostic imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinicians will recruit men and women diagnosed with a suspected glioblastoma who are scheduled to undergo neurosurgical resection and/or chemoradiation therapy as treatment.

You may qualify if:

• Aged between 18 and 75 years
• Diagnosed with suspected glioblastoma
• Eligible for neurosurgical resection and/or chemoradiation therapy.

You may not qualify if:

• Younger than 18 years old
• Patients unfit for surgery or lesions unsuitable for neurosurgical treatment

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 19, 2022
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: December 19, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share