2024-517358-86-00RecruitingPhase 2
MR-HYPERPOLARISATION SCANNING WITH HYPERPOLARISED PYRUVATE (13C) IN PANCREATIC CANCER PATIENTS – A FEASIBILITY STUDY
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 22 Aug 2024
- Start date
- 13 Sept 2024
- Lead sponsor
- Aarhus Universitet
- Diseases
- Pancreatic cancer
- EU CT number
- 2024-517358-86-00
- EudraCT number
- 2016-004491-22
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 16
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not able or willing to receive chemotherapy
- Previous or current radiotherapy or chemotherapy
Other illness
- Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia or cardiac events
- History of acute or chronic pancreatitis
- Acute or chronic liver disease incl. cirrhosis
Other
- Contraindications to contrast enhanced MRI
- Predicted remaining survival <3 months
- Contraindication to contrast enhanced CT
- Patients not willing to participate
- Intolerant to Pyruvate
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus Universitetshospital | Aarhus N | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.