Overview
Sponsor-declared trial summary
glioblastoma multiforme
We hypothesis that tumor and therapy related changes in the brain tissue are associated with altered metabolic profiles and this is detectable with hyperpolarized [1-13C]pyruvate MRI.
Key facts
- Sponsor
- Aarhus Universitet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Apr 2020 → ongoing
- Decision date (initial)
- 2024-07-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515408-37-00
- EudraCT number
- 2020-000310-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Others
We hypothesis that tumor and therapy related changes in the brain tissue are associated with altered
metabolic profiles and this is detectable with hyperpolarized [1-13C]pyruvate MRI.
Conditions and MedDRA coding
glioblastoma multiforme
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Patients with newly diagnosed high-grade glioma (grade 3 and 4)
- Scheduled for radiotherapy
- At least 18 years of age
- WHO performance status 0-2
- Women who are not postmenopausal or surgically sterile must have a negative serum or urine pregnancy test performed at time of inclusion in the study. Safe and highly effective contraception must be used throughout the study meaning either hormonal anti-conception or an anti-fertility intrauterine device. If the partner is non fertile or the patient has no sexual activities, this is also accepted.
- Danish speaking
- Able and willing to comply after informed consent
Exclusion criteria 9
- History of alcohol abuse or illicit drug use.
- Allergy to pyruvate
- Contraindications to MRI o Pacemaker, neurostimulator or cochlea implant o Metal foreign bodies such as fragments and irremovable piercings o Unsafe medical implants (safety of heart valves, hips and the like must be confirmed) o Intracranial clips or coils o Claustrophobia o Largest circumference including arms > 160 cm
- Contraindications to gadolinium contrast o eGFR ≤ 30 mL/min/1.73m2 o Previous adverse reactions to gadolinium
- Not able or willing to receive radiotherapy
- Predicted remaining survival <3 months
- Symptomatic cardiac disease (i.e. valve disease, coronary artery disease, arrythmias etc.). Hypertension and hyperlipidemia are allowed.
- Subjects who are receiving any other investigational agents.
- Previous or current treatment by radiation or chemotherapy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- [1-13C]pyruvate perfusion, uptake and conversion to [1-13C]lactate, [1-13C]alanine and [13C] bicarbonate in normal brain and tumor tissue
Secondary endpoints 6
- Perfusion (DCE MRI)
- Microvascular diffusion (ADC MRI)
- Amide proton transfer weight (APT) imaging
- Progression-free survival (PFS)
- Overall survival (OS)
- Radiation dose distribution
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hyperpolarized [1-13C]pyruvate
PRD10284730 · Product
- Active substance
- Pyruvic Acid
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 0.43 millilitre(s)/kilogram
- Max total dose
- 0.43 millilitre(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus Universitet
- Sponsor organisation
- Aarhus Universitet
- Address
- Palle Juul-Jensens Boulevard 82
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus Universitet
- Contact name
- The MR Research Centre
Public contact point
- Organisation
- Aarhus Universitet
- Contact name
- The MR Research Centre
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2020-04-01 | 2024-10-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol | 1.4 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation | 1.3 |
| Subject information and informed consent form (for publication) | Forsoegspersoners rettigheder | 1 |
| Subject information and informed consent form (for publication) | informed consent | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-19 | Denmark | Acceptable 2024-07-08
|
2024-07-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-28 | Denmark | Acceptable 2024-07-08
|
2025-11-28 |