Clinical trial • Phase IV • Oncology
IRON OXIDE (E172) for Glioblastoma
Phase IV trial of IRON OXIDE (E172) for Glioblastoma. open-label, none/not specified-controlled. 21 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Glioblastoma
- Trial Stage
- Phase IV
- Drug Modality
- Diagnostic agent
Key dates
- Initial CTIS Submission Date
- 11-11-2024
- First CTIS Authorization Date
- 02-12-2024
Trial design
open-label, none/not specified-controlled Phase IV trial across 1 site in Netherlands.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 21
Eligibility
Recruits 21 No vulnerable population selected (isVulnerablePopulationSelected=false). Participants are adults (age 18-75); specific consent/assent handling not detailed in the available record..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). Participants are adults (age 18-75); specific consent/assent handling not detailed in the available record.
Inclusion criteria
- {"criterion_text":"- Diagnosed with suspected glioblastoma"}
- {"criterion_text":"- Age between 18-75 years"}
- {"criterion_text":"- Eligible for neurosurgical resection and/or chemoradiation therapy."}
Exclusion criteria
- {"criterion_text":"- Younger than 18 years"}
- {"criterion_text":"- Patients unfit for surgery or lesions unsuitable for neurosurgical treatment"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Dose optimisation for USPIO assessed by neuro-imaging signal-to-noise ratio optimization; obtained images reviewed by a panel of radiologists to assess image quality and diagnostic performance."}
Secondary endpoints
- {"endpoint_text":"- Perform MR imaging of glioblastoma by use of a new Off Road multi-sequence protocol (i.e., T1w, T2w, FLAIR, DWI/DTI, SWI, QSM, T1w- and T2*w post-USPIO images) in 15 GBM patients.","definition_or_measurement_approach":"MR imaging using the specified multi-sequence Off Road protocol in 15 GBM patients, including pre- and post-USPIO sequences as listed."}
Recruitment
- Planned Sample Size
- 21
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent obtained from adult participants. Separate subject information and informed consent forms exist for healthy adults and for patient adults (documents listed), but specific wording, languages, and assent processes are not provided in the available record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 15
Netherlands
- Earliest CTIS Part Ii Submission Date
- 28-11-2024
- Latest Decision Or Authorization Date
- 02-12-2024
- Processing Time Days
- 4
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Medical Imaging
- Contact Person Name
- Dylan Henssen
- Contact Person Email
- Dylan.henssen@radboudumc.nl
- Number Of Participants
- 15
Sponsor
Primary sponsor
- Full Name
- Stichting Radboud universitair medisch centrum
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- IRON OXIDE (E172)
- Active Substance
- IRON OXIDE (E172)
- Modality
- Diagnostic agent
- Routes Of Administration
- Intravascular use
- Route
- Intravascular use
- Maximum Dose
- 4 mg/kg
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