MR-HYPERPOLARISATION SCANNING WITH HYPERPOLARISED PYRUVATE (13C) IN PANCREATIC CANCER PATIENTS – A FEASIBILITY STUDY
Key facts
- Where
- Aarhus N, DániaSee the site
- Phase
- 2. fázis
Where in Dánia
- Aarhus UniversitetshospitalAarhus N, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aarhus Universitet
- Trial code
- EU 2024-517358-86-00
- Record updated
- 2025. szeptember 25.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Not able or willing to receive chemotherapy; Previous or current radiotherapy or chemotherapy; 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; Contraindications to contrast enhanced MRI; Predicted remaining survival <3 months; Contraindication to contrast enhanced CT; Patients not willing to participate; Intolerant to Pyruvate.