Overview
Sponsor-declared trial summary
Pancreatic Cancer
To optimise the MR-hyperpolarisation scanning technique in patients using a dose of 13C-Pyruvate established as safe in previous phase I/II-studies. To obtain baseline data on 13C-Pyruvate MR-hyperpolarisation signals in selected anatomical sites including tumorous pancreas, non-tumorous pancreas, liver metastases and …
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] - Investigative Techniques [E05]
- Trial duration
- 13 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517358-86-00
- EudraCT number
- 2016-004491-22
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To optimise the MR-hyperpolarisation scanning technique in patients using a
dose of 13C-Pyruvate established as safe in previous phase I/II-studies.
To obtain baseline data on 13C-Pyruvate MR-hyperpolarisation signals in
selected anatomical sites including tumorous pancreas, non-tumorous
pancreas, liver metastases and normal liver.
To confirm safety and feasibility of infusion of 13C-Pyruvate in patients with
pancreatic cancer.
To explore correlations between 13C-Pyruvate MR-hyperpolarisation signals
and evidence of clinical response to chemotherapy to be tested in further
phase II-studies.
Conditions and MedDRA coding
Pancreatic Cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Patients with inoperable (metastatic, locally advanced or localised)or relapsedhistologically or cytologically verified pancreatic adenocarcinoma
- Scheduled for first-line palliative chemotherapy of any type or having received at least 4 cycles of chemotherapy
- At least 18 years of age
- WHO performance status 0-2
- Adequate hematologic and organ function, i.e. ANC at least 1.500/uL Platlet count >100/uL Se bilirubin <1.5 UNL ASAT, ALAT and AP up to 2.5 x UNL, up to 5 x UNL with liver metastases Se creatinine up to 1.5 x UNL or creatinine clearance at least 30 ml/min INR and aPTT at most 1.5 x UNL, except for patients on AK treatment
- Women who are not postmenopausal or surgically sterile must have a negative serum or urin 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 10
- Contraindications to contrast enhanced MRI
- Contraindication to contrast enhanced CT
- Not able or willing to receive chemotherapy
- Patients not willing to participate
- Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia or cardiac events
- Previous or current radiotherapy or chemotherapy
- History of acute or chronic pancreatitis
- Acute or chronic liver disease incl. cirrhosis
- Intolerant to Pyruvate
- Predicted remaining survival <3 months
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- C13-Pyruvate spectroscopy imaging generates spectroscopic parameters (quantitative data for lactate, pyruvate, arginine and HCO3-). These will be projected 07-07-22 Projektbeskrivelse: MR-hyperpolarization 8. Version. Page 25 into a high-resolution anatomical image. The quantitative numerical data will be given as ratios, e.g. lactate/pyruvate-ratio, which gives us the possibility to perform comparisons between non-tumor vs. tumor tissue and pre-chemo vs. post-chemo.
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
- Max daily dose
- 250 mmol/l millimole(s)/litre
- Max total dose
- 500 mmol/l millimole(s)/litre
- Max treatment duration
- 1 Month(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 11
- 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 | 16 | 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 | 2024-09-13 | 2025-09-01 |
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 | 9.1 |
| Protocol (for publication) | Protocol w track changes | 9.1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Subject information | 6.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-22 | Denmark | Acceptable 2024-09-13
|
2024-09-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-11 | Denmark | Acceptable 2025-02-14
|
2025-02-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-25 | Denmark | Acceptable 2025-02-14
|
2025-09-25 |