Overview
Sponsor-declared trial summary
Primary liver cancer
This project seeks to determine the potential of hyperpolarized pyruvate MRI in early characterization of primary liver cancer - particularly small tumors.
Key facts
- Sponsor
- Aarhus Universitet
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 19 Jun 2023 → ongoing
- Decision date (initial)
- 2024-07-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512490-27-00
- EudraCT number
- 2021-000863-56
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
This project seeks to determine the potential of hyperpolarized pyruvate
MRI in early characterization of primary liver cancer - particularly small
tumors.
Conditions and MedDRA coding
Primary liver cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- - Aged 18 – 85 years. The age and gender of the healthy controls of the main study will be matched to the participating patients.
- - Pre-menopausal women must be confirmed non-pregnant by an onsite test
- • HCC group: - Diagnosed HCC larger than 10 mm confirmed by standard MRI, CT or confirmed by tumour biopsy. - Subgroup 1: Not elected for liver surgery - Subgroup 2: Elected for liver surgery
- • Small tumor group: - One or more small lesions in the liver requiring 2 years of repeated follow-up as per the EASL guideline. Could be in a liver with a confirmed HCC.
Exclusion criteria 14
- - Chronic kidney disease
- - Patients with tumors must have eGFR > 30 ml/min/1.73m2
- - Significant cardiac disease (as left ventricular outflow obstruction or heart failure)
- - Significant obstructive lung disease or severe asthma
- - Pacemaker, neurostimulator or cholera implant
- - Metal foreign bodies such as fragments and irremovable piercings
- - Unsafe medical implants (safety of heart valves, hips and the like must be confirmed)
- - Largest circumference including arms > 160 cm
- - Claustrophobia
- • Contraindications for MRI with contrast:
- • Competing systemic disease (hypertension, dyslipidemia, diabetes etc. allowed)
- • Hepatic encephalopathy ≥ grade 2.
- • Stents or other devices implanted close to the liver that may cause imaging artefacts
- • Allergy to pyruvate
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The raw data will be processed using both model-free and kinetic modeling approaches, which are the standards of analyzing hyperpolarized pyruvate MRI data, to quantify metabolism and perfusion.
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
- Christoffer Laustsen
Public contact point
- Organisation
- Aarhus Universitet
- Contact name
- Christoffer Laustsen
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 | 46 | 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 | 2023-06-19 | 2023-06-26 |
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) | Protocol | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation | 1 |
| Subject information and informed consent form (for publication) | Samtykkeerklring | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-08 | Denmark | Acceptable 2024-07-18
|
2024-07-25 |