Overview
Sponsor-declared trial summary
Glioblastoma
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?
Key facts
- Sponsor
- Stichting Radboud universitair medisch centrum
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-12-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514013-34-00
- EudraCT number
- 2023-000068-80
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
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?
Conditions and MedDRA coding
Glioblastoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Diagnosed with suspected glioblastoma
- Age between 18-75 years
- Eligible for neurosurgical resection and/or chemoradiation therapy.
Exclusion criteria 2
- Younger than 18 years
- Patients unfit for surgery or lesions unsuitable for neurosurgical treatment
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB16058MIG · Substance
- Active substance
- Iron Oxide (E172)
- Pharmaceutical form
- CONCENTRATE FOR DISPERSION FOR INFUSION
- Route of administration
- INTRAVASCULAR USE
- Max daily dose
- 1 mg/kg milligram(s)/kilogram
- Max total dose
- 4 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud universitair medisch centrum
- Sponsor organisation
- Stichting Radboud universitair medisch centrum
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Dylan Henssen
Public contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Dylan Henssen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol_ 2024-514013-34-00 | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements 2024-514013-34-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF healthy adults | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patients adults | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-11 | Netherlands | Acceptable 2024-12-02
|
2024-12-02 |